Ein globales Pharmaunternehmen in Dublin sucht einen Senior Manager für Regulatory Affairs. In dieser Rolle sind Sie verantwortlich für das Management globaler Regulierungsstrategien und die Sicherstellung der Compliance in allen Märkten. Die Anforderungen umfassen umfangreiche CMC-Autorenerfahrung, Kenntnisse der regulatorischen Anforderungen, sowie hervorragende Kommunikationsfähigkeiten. Sie haben die Chance, in einem dynamischen Umfeld mit einem engagierten Team zu arbeiten, das darauf abzielt, die Gesundheitsversorgung weltweit zu verbessern. #J-18808-Ljbffr
Senior Manager, Regulatory Affairs page is loaded## Senior Manager, Regulatory Affairslocations: Northern Cross, Dublin, Irelandtime type: Vollzeitposted on: Heute ausgeschriebenjob requisition id: R5665831McDermott Laboratories LimitedBei VIATRIS, sehen wir das Gesundheitswesen nicht so, wie es ist, sondern so, wie es sein sollte. Wir handeln entschlossen, und unsere einzigartige Positionierung sorgt für Stabilität in einer Welt, in der sich die Bedarfe im Gesundheitswesen stets verändern. Viatris befähigt Menschen in allen Teilen der Welt, in jeder Lebensphase gesünder zu leben. Dies erreichen wir durch:*Zugang* – Zugang zu hochwertigen, bewährten Arzneimitteln und Impfstoffen sowie auch neu entwickelten Biosimilars für Patienten in allen Lebensumständen weltweit*Führungsverantwortung* – Verbesserung der Patientengesundheit durch zukunftsgerichtete nachhaltige Unternehmensführung und innovative Lösungen*Partnerschaft* – Optimaler Einsatz unserer Kompetenzen, um Menschen den Zugang zu Produkten und Dienstleistungen zu ermöglichen.Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.**The Role & What You Will Be Doing**The Senior Manager Global Branded CMC Strategy possesses CMC regulatory knowledge and quality expertise to independently prepare regulatory assessments & contribute to global regulatory strategies for projects across all aspects of drug development or manufacturing lifecycle and works to support the Upjohn portfolio.Every day, we rise to the challenge to make a difference and here’s how the **Senior Manager, Regulatory Affairs**role will make an impact:* Ensure global regulatory compliance with external requirements and internal quality procedures across all markets.* Apply sound regulatory judgment, strategic thinking, and business acumen to develop and implement global regulatory strategies.* Prepare, review, and deliver high-quality CMC submissions for new registrations, post-approval changes, renewals, and responses to agency queries.* Lead CMC activities for assigned projects, including submission planning, risk assessment, and regulatory timelines tracking.* Represent CMC on cross-functional project teams, ensuring alignment with scientific, technical, and regulatory criteria.* Maintain up-to-date regulatory documentation and systems, manage commitments, and ensure submission compliance.* Collaborate effectively with internal and external stakeholders, including Regulatory, Quality, R&D, and global/regional teams.* Serve as a technical and scientific resource for complex regulatory issues and provide mentoring to colleagues.* Support implementation of regulatory policies, procedures, and continuous improvement initiatives across CMC functions.* Build and maintain professional relationships with regulatory authorities and industry bodies to enhance regulatory success.* Contribute to CMC-related projects, training, and development programs, while modeling Viatris’ values and behaviors.* Participate in external forums, trade groups, or industry conferences relevant to CMC functions as needed.**About Your Skills & Experience**For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:* Mandatory hands-on CMC authoring experience (initial registrations or post-approval variations)* Sufficient level of knowledge and solid understanding of the development and commercial activities and cGMP’s required to assess technical, scientific and regulatory merits of CMC information, commitments and data to lead teams and/or project(s).* Advanced technical, functional, and industry knowledge to shape strategic direction of assigned project(s), reduce regulatory burden and improve regulatory flexibility commensurate with business needs.* Advanced knowledge of regulatory requirements and expectations, criteria for submission and approval globally and experience of interactions with regulatory authorities for projects.* Sound understanding and advanced knowledge of the principles, practices and concepts of regulatory CMC/ policy/ publishing disciplines and a working knowledge of the principles, practices, concepts and operations in other relevant disciplines.* Advanced skills in written & oral communications (mandatory).* Computer literacy with Microsoft Office Suite and Documentum-based applications.* Project Management skills* Ability to engage in the external regulatory and pharmaceutical environment.* Some experience serving as a Subject Matter Expert in specific relevant disciplines or as a resource for specific pharmaceutical science projects in specific regulatory domain(s).At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.**Diversity & Inclusion at Viatris**At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit**Sustainability at Viatris**Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visitBei Viatris, bieten wir wettbewerbsfähige Gehälter, Sozialleistungen und ein integratives Umfeld, in dem Sie Ihre Erfahrungen, Perspektiven und Fähigkeiten einsetzen können, um das Leben anderer zu beeinflussen. #J-18808-Ljbffr
Senior Manager, Regulatory Affairs page is loaded## Senior Manager, Regulatory Affairslocations: Northern Cross, Dublin, Irelandtime type: Tiempo completoposted on: Publicado hoyjob requisition id: R5665831McDermott Laboratories LimitedEn VIATRIS, vemos la atención médica no como es, sino como debería de ser. Actuamos con valentía y estamos en una posición única para ser una fuente de estabilidad en un mundo de necesidades de atención médica en constante evolución.Viatris ayuda a las personas de todo el mundo a vivir de manera más saludable en cada etapa de la vida.Lo hacemos a través de:Acceso – suministrando medicamentos de confianza y de alta calidad independientemente de la geografía o las circunstancias;Liderazgo – promoviendo operaciones sostenibles y soluciones innovadoras para mejorar la salud del paciente;Colaboración – aprovechando nuestra experiencia común para conectar a las personas con productos y servicios.Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.**The Role & What You Will Be Doing**The Senior Manager Global Branded CMC Strategy possesses CMC regulatory knowledge and quality expertise to independently prepare regulatory assessments & contribute to global regulatory strategies for projects across all aspects of drug development or manufacturing lifecycle and works to support the Upjohn portfolio.Every day, we rise to the challenge to make a difference and here’s how the **Senior Manager, Regulatory Affairs**role will make an impact:* Ensure global regulatory compliance with external requirements and internal quality procedures across all markets.* Apply sound regulatory judgment, strategic thinking, and business acumen to develop and implement global regulatory strategies.* Prepare, review, and deliver high-quality CMC submissions for new registrations, post-approval changes, renewals, and responses to agency queries.* Lead CMC activities for assigned projects, including submission planning, risk assessment, and regulatory timelines tracking.* Represent CMC on cross-functional project teams, ensuring alignment with scientific, technical, and regulatory criteria.* Maintain up-to-date regulatory documentation and systems, manage commitments, and ensure submission compliance.* Collaborate effectively with internal and external stakeholders, including Regulatory, Quality, R&D, and global/regional teams.* Serve as a technical and scientific resource for complex regulatory issues and provide mentoring to colleagues.* Support implementation of regulatory policies, procedures, and continuous improvement initiatives across CMC functions.* Build and maintain professional relationships with regulatory authorities and industry bodies to enhance regulatory success.* Contribute to CMC-related projects, training, and development programs, while modeling Viatris’ values and behaviors.* Participate in external forums, trade groups, or industry conferences relevant to CMC functions as needed.**About Your Skills & Experience**For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:* Mandatory hands-on CMC authoring experience (initial registrations or post-approval variations)* Sufficient level of knowledge and solid understanding of the development and commercial activities and cGMP’s required to assess technical, scientific and regulatory merits of CMC information, commitments and data to lead teams and/or project(s).* Advanced technical, functional, and industry knowledge to shape strategic direction of assigned project(s), reduce regulatory burden and improve regulatory flexibility commensurate with business needs.* Advanced knowledge of regulatory requirements and expectations, criteria for submission and approval globally and experience of interactions with regulatory authorities for projects.* Sound understanding and advanced knowledge of the principles, practices and concepts of regulatory CMC/ policy/ publishing disciplines and a working knowledge of the principles, practices, concepts and operations in other relevant disciplines.* Advanced skills in written & oral communications (mandatory).* Computer literacy with Microsoft Office Suite and Documentum-based applications.* Project Management skills* Ability to engage in the external regulatory and pharmaceutical environment.* Some experience serving as a Subject Matter Expert in specific relevant disciplines or as a resource for specific pharmaceutical science projects in specific regulatory domain(s).At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.**Diversity & Inclusion at Viatris**At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit**Sustainability at Viatris**Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visitEn Viatris, ofrecemos salarios competitivos, beneficios y un entorno inclusivo donde puede usar sus experiencias, perspectivas y habilidades para ayudar a generar un impacto en la vida de los demás.Viatris es una compañía global del cuidado de la salud creada en 2020 a través de la combinación de Mylan y Upjohn, una división legada de Pfizer. Al integrar las fortalezas de estas dos compañías, incluida nuestra fuerza laboral global de aprox. 45,000, nuestro objetivo es proporcionar acceso mejorado a medicamentos de calidad asequibles a pacientes de todo el mundo, independientemente de dónde vivan o de las circunstancias. Creemos en el cuidado de la salud como debe ser: empoderamos a las personas de todo el mundo para que vivan de manera más saludable en cada etapa de la vida. Debido a nuestra creencia firme de que un acceso mejorado permite una mejor salud, aprovechamos nuestra experiencia científica y de manufactura inmejorable, al igual que las capacidades comerciales comprobadas, para ofrecer a los pacientes medicamentos de calidad en el momento y en el lugar que los necesiten. #J-18808-Ljbffr
Una empresa farmacéutica global busca un Senior Manager en Regulatory Affairs para asegurar el cumplimiento regulatorio global y liderar estrategias regulatorias en proyectos de desarrollo de medicamentos. Buscamos un candidato con experiencia en autoría CMC y habilidades avanzadas en comunicación. La posición ofrece un ambiente inclusivo, oportunidades de progreso en la carrera y un paquete de compensación competitivo. #J-18808-Ljbffr
Director, Device Design and Product Industrialisation page is loaded## Director, Device Design and Product Industrialisationlocations: Northern Cross, Dublin, Irelandtime type: Vollzeitposted on: Vor 5 Tagen ausgeschriebenjob requisition id: R5652625Mylan Pharma UK LimitedBei VIATRIS, sehen wir das Gesundheitswesen nicht so, wie es ist, sondern so, wie es sein sollte. Wir handeln entschlossen, und unsere einzigartige Positionierung sorgt für Stabilität in einer Welt, in der sich die Bedarfe im Gesundheitswesen stets verändern. Viatris befähigt Menschen in allen Teilen der Welt, in jeder Lebensphase gesünder zu leben. Dies erreichen wir durch:*Zugang* – Zugang zu hochwertigen, bewährten Arzneimitteln und Impfstoffen sowie auch neu entwickelten Biosimilars für Patienten in allen Lebensumständen weltweit*Führungsverantwortung* – Verbesserung der Patientengesundheit durch zukunftsgerichtete nachhaltige Unternehmensführung und innovative Lösungen*Partnerschaft* – Optimaler Einsatz unserer Kompetenzen, um Menschen den Zugang zu Produkten und Dienstleistungen zu ermöglichen.Our Global Device Development organisation is focused on the design, development and commercialisation of a diverse portfolio of device technology solutions to enable delivery for our large and growing range of generic and branded products around the globe. We develop device technologies to enable drug-delivery for respiratory, biologic, biosimilar and injectable products, and work across Viatris to support innovative technology in the healthcare solutions for our patients. We operate from 4 sites: Dublin, Ireland, Cambridge & Sandwich, UK and Southpointe, Pittsburgh, USA. Every member of our team is dedicated to creating better health for a better world, one person at a time.With an expanding portfolio of products and exciting new projects in the pipeline, we need to grow and we are looking for talented engineers to join the team. The Director, Device Design and Industrialization role is a lead role for an experienced manager with a MSc in design/mechanical engineering in combination product design and development, and here’s how this role will make an impact:Key responsibilities for this role include:* Manage the team to develop drug delivery devices, you will apply your technical skills, insights, and management experience to meet the challenges of evolving industry standards, commercial requirements, regulatory and user requirements.* Providing mentorship/coaching to the design & development team contributing to their personal development and professional growth.* Lead with experience of device design, materials, and manufacturing processes, to bring technical leadership to device development projects.* Lead & ensure solid engineering principles, calculations, tolerance analysis, and CAE simulation techniques to drive design activities, evaluate and address technical risks and establish mitigations and coach others to do the same.* Apply critical thinking to navigate complex constraints in the design space to achieve robust, cost-effective, functional device designs, ensuring designs will be capable of meeting performance and reliability requirements in high volume manufacture.* Contribute to strategic and technical elements of the wider R&D product development programmes aligned with experience and technical expertise.The minimum qualifications for this role are:* MSc in design/mechanical engineering.* Excellent technical skills and passion for design & mechanical engineering of (delivery systems), combination products from concept through to industrialization.* Excellent management skills with proven people development experience* Experienced with 3D CAD; Creo and/or Solidworks, analysis of tolerances, and simulation techniques (FEA, CFD) as applied to development of high-volume products* Experienced with the principles of Design Control within ISO 13485 & FDA 21 CFR Part 820.* Strong work ethic, excellent communication skills and teamwork are essential.* International travel will be required as part of this role.At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.Bei Viatris, bieten wir wettbewerbsfähige Gehälter, Sozialleistungen und ein integratives Umfeld, in dem Sie Ihre Erfahrungen, Perspektiven und Fähigkeiten einsetzen können, um das Leben anderer zu beeinflussen. #J-18808-Ljbffr
Specialist RIM Data Maintenance page is loaded## Specialist RIM Data Maintenancelocations: Northern Cross, Dublin, Irelandtime type: Tiempo completoposted on: Publicado hoyjob requisition id: R5665690McDermott Laboratories LimitedEn VIATRIS, vemos la atención médica no como es, sino como debería de ser. Actuamos con valentía y estamos en una posición única para ser una fuente de estabilidad en un mundo de necesidades de atención médica en constante evolución.Viatris ayuda a las personas de todo el mundo a vivir de manera más saludable en cada etapa de la vida.Lo hacemos a través de:Acceso – suministrando medicamentos de confianza y de alta calidad independientemente de la geografía o las circunstancias;Liderazgo – promoviendo operaciones sostenibles y soluciones innovadoras para mejorar la salud del paciente;Colaboración – aprovechando nuestra experiencia común para conectar a las personas con productos y servicios.Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.**The Role & What You Will Be Doing**RIM Data Maintenance Specialist will provide user support for record creation and maintenance of records in the Regulatory Information Management (RIM) system (Veeva Registrations), address RIM related user questions and support with data cleansing and data compliance checks for information maintained in RIMS.Every day, we rise to the challenge to make a difference and here’s how the **RIM Data Maintenance Specialist** role will make an impact:* Partner with the Regulatory teams on the creation/revision of records in the RIM system for a large, global portfolio of pharmaceutical products. This includes the creation of Application-level records, as well as Master Data level records.* Collaborate with the Regulatory Affairs team to address queries related to the RIM system for field definitions, data entry standards, system workflows, dashboards, searches, etc.* Participate in data cleansing operations to facilitate appropriate and timely access to data for key systems.* Support the evaluation of data quality issues through the review/analysis of system generated consistency checks. Work with Regulatory colleagues to address items.* Collaborate with the Regulatory Affairs team to help with bulk updates.* Submit master data requests for dictionary updates to the RIM system.* Propose improvements to the RIM system, processes, or procedures based on experience with use of the system.* Contribute to the development and implementation of departmental Standard Operating Procedures (SOPs), user manuals, and data standards.**About Your Skills & Experience**For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:* BS/BA in technology field, life sciences field, or other relevant discipline* Previous experience in pharmaceutical industry.* Experience in Regulatory Affairs or Regulatory Operations is strongly preferred. Other pharmaceutical experience (e.g. Research & Development, Quality Assurance/Compliance) will be considered.At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.**Diversity & Inclusion at Viatris**At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit**Sustainability at Viatris**Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visitEn Viatris, ofrecemos salarios competitivos, beneficios y un entorno inclusivo donde puede usar sus experiencias, perspectivas y habilidades para ayudar a generar un impacto en la vida de los demás.Viatris es una compañía global del cuidado de la salud creada en 2020 a través de la combinación de Mylan y Upjohn, una división legada de Pfizer. Al integrar las fortalezas de estas dos compañías, incluida nuestra fuerza laboral global de aprox. 45,000, nuestro objetivo es proporcionar acceso mejorado a medicamentos de calidad asequibles a pacientes de todo el mundo, independientemente de dónde vivan o de las circunstancias. Creemos en el cuidado de la salud como debe ser: empoderamos a las personas de todo el mundo para que vivan de manera más saludable en cada etapa de la vida. Debido a nuestra creencia firme de que un acceso mejorado permite una mejor salud, aprovechamos nuestra experiencia científica y de manufactura inmejorable, al igual que las capacidades comerciales comprobadas, para ofrecer a los pacientes medicamentos de calidad en el momento y en el lugar que los necesiten. #J-18808-Ljbffr
QC Analyst lll page is loaded## QC Analyst llllocations: Inverin, County Galway, Irelandtime type: Temps pleinposted on: Offre publiée aujourd'huijob requisition id: R5665660Mylan TeorantaChez Viatris, nous envisageons la santé non pas telle qu'elle est mais telle qu'elle devrait être. Nous agissons avec courage et notre positionnement unique est source de stabilité dans un monde où les besoins en matière de santé sont en constante évolution. Viatris permet à chacun dans le monde entier de vivre en meilleure santé à chaque étape de sa vie. Via trois axes majeurs:*Accès*: En fournissant des médicaments de haute qualité et reconnus, quels que soient le lieu de résidence ou la situation de chaque patient.*Leadership*: En favorisant l’évolution de nos activités de façon durable et le développement de solutions innovantes pour améliorer la santé des patients.*Partenariat*: En valorisant notre expertise collective afin de donner accès à tous à nos produits et services.Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.**The Role & What You Will Be Doing**The Quality Control (QC) Analyst III will be primarily responsible for the advanced chromatographic and wet chemistry analysis of raw materials, in-process, finished product and stability product samples and completing the relevant GMP documentation.Every day, we rise to the challenge to make a difference and here’s how the **Quality Control (QC) Analyst III** role will make an impact:* Conduct routine chromatographic (HPLC and GC, but primarily HPLC) and wet chemistry testing of raw materials, in process, finished product and stability samples in strict compliance with GLP & cGMP procedures.* Assist in the transfer (and troubleshooting, where required) of analytical methods to the QC laboratory as and when required.* Co-ordinate and supervise laboratory investigations to ensure they are captured, documented and actioned with close out in a timely manner. Ensure OOS results are escalated and where relevant FARs are required they are initiated within the required timeline.* Assist in chromatography and wet chemistry training of other QC analysts* Review and approve non-chromatographic and chromatographic data.* Present as subject matter expert during third party inspections as required.* Support continuous improvement projects such as 6S and lean processes for the laboratory* Management of QC SOPs, change controls, deviations and IRFs.* Conduct calibration and maintenance of wet chemistry/chromatography instrumentation.* Participate in department projects, as assigned by QC Team Leader/QC Manager**About Your Skills & Experience**For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:* Minimum of a Bachelor's degree (or equivalent) in a Science related discipline ( Chemistry, Biochemistry or Analytical science) and 5+ years of relevant industrial experience. Previous HPLC/GC/ peptide analysis experience in method validation / transfer (preferably with Empower software) is essential.* Strong working knowledge of chemistry / biochemistry (chromatographic, wet chemistry and peptide analysis) techniques.* Strong technical writing skills.* Empower and other lab software systems.* cGMP* Computer skills (MS Office, Trackwise, Minitab, LIMS).* College level mathematics ability required.* Ability to solve practical problems through standardized solutions that require limited judgment. Ability to follow prescribed and detailed procedures to solve routine problems.At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.**Benefits at Viatris**At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Some of our benefits include the following on top of a competitive salary:* Excellent career progression opportunities* Work-life balance initiatives* Bonus scheme* Health insurance* Pension**Diversity & Inclusion at Viatris**At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit**Sustainability at Viatris**Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visitChez Viatris, nous proposons des salaires compétitifs, des bénéfices et un environnement inclusif au sein duquel vous pouvez mettre à profit votre expérience, vos perspectives et vos compétences pour aider à avoir un impact positif sur la vie des autres.Viatris est une entreprise mondiale de services de santé créée en 2020 par la combinaison de Mylan et Upjohn, une division héritée de Pfizer. En intégrant les atouts de ces deux entreprises, y compris notre main-d’œuvre mondiale d’environ 45 000 personnes, nous visons à offrir un accès accru à des médicaments abordables et de qualité pour les patients du monde entier, indépendamment de la géographie ou des circonstances. Nous croyons aux services de santé comme ils devraient l’être, permettant aux personnes du monde entier de vivre plus sainement à chaque étape de la vie. Et parce que nous croyons fermement qu’un meilleur accès aux soins conduit à une meilleure santé, nous réunissons des compétences scientifiques et logistiques d’excellence, ainsi que des expertises commerciales éprouvées pour fournir des médicaments de qualité aux patients, où et quand ils en ont besoin. #J-18808-Ljbffr
**Cookie Notice**Director Respiratory Regulatory CMC page is loaded## Director Respiratory Regulatory CMClocations: Northern Cross, Dublin, Ireland: Sandwich, England, United Kingdom: United Kingdom Remote Office: Hatfield, England, United Kingdomtime type: Full timeposted on: Posted 2 Days Agojob requisition id: R5665371Mylan Pharma UK LimitedAt VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access – Providing high quality trusted medicines regardless of geography or circumstance; Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and Partnership – Leveraging our collective expertise to connect people to products and services. Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.**The Role & What You Will Be Doing**Every day, we rise to the challenge to make a difference and here’s how the **Director Respiratory Regulatory CMC** role will make an impact:* Cultivates sustainable & effective relationships across a network of stakeholders, partners and customers to drive and establish aligned approaches to regulatory strategies and/or policies.* Uses technical and scientific knowledge in the preparation and analysis of global CMC submission documentation and maintenance of product compliance and management of CMC change control. Guides preparation of CMC submission documentation where assigned* Serves as a liaison with regulatory agencies for specific topics and providing oversight for the fulfillment of agency commitments and providing responses to agency queries. Responsibilities include the lead in preparations and interactions for regulatory authority meetings* Manages, leads and contributes significantly to the respiratory portfolio, individual projects and initiatives within cross-functional project teams.* Participates, as required, in pharmaceutical industry conferences or serves externally as a representative to pharmaceutical trade group advisory committees relevant to CMC functions. Monitor the external competitor and regulatory environment and build knowledge into project strategies.* Performs other duties or equivalent duties for other product types as assigned* Serves as the primary reviewer of global CMC strategic plans and documentation/submissions for the assigned products (primarily within the respiratory product portfolio)**About Your Skills & Experience**For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:* Mandatory hands-on CMC authoring experience (initial registrations or post-approval variations)* Mandatory hands-on experience in Regulatory CMC for respiratory/inhaled products* High level of knowledge of development & commercial activities and cGMP’s to assess technical, scientific & regulatory merits of CMC information, commitments and data to lead teams and/or complex projects. Specific knowledge in development and life cycle management of respiratory/inhaled products is highly preferred* Extensive technical, functional, and industry knowledge in shaping project strategy, reducing regulatory burden & improving regulatory flexibility across global markets and diverse therapeutic areas. Independently capable of executing activities related to complex projects across all aspects of drug development and commercial manufacturing product lifecycle. Specific knowledge in development of respiratory/inhaled products or other combination product types with similar complexity is highly preferred* Advanced understanding of current and emerging regulatory requirements & expectations, criteria for submission & approval globally, & experience in leading negotiations and interactions with regulatory authorities for projects and/or policy initiatives.* Possesses sound understanding of business expectations across partner lines, with proven ability to partner successfully with other Regulatory functions, Manufacturing & Supply Chain, Quality, Safety, Medical, Commercial, Legal and senior stakeholders to achieve objectives.* Advanced skills in written & oral communications (mandatory).* Computer literacy with Microsoft Office Suite and Documentum-based applications.* Prior experience managing projects and matrixed teams and/or serving as a people manager* Ability to participate in interactions with regulatory authorities to respond to requests either directly or in conjunction with Regulatory Affairs personnel.* Demonstrated commitment & dedication to scientific & regulatory integrity & quality compliance.* Ability to engage in the external regulatory and pharmaceutical environment.* Proven ability to deliver to time, cost and quality standards* Demonstrated strategic thinking and ability to integrate strategies into actionable plans* Demonstrated experience serving as a Subject Matter Expert in specific relevant disciplines or as a recognized resource for specific pharmaceutical science projects and/or specialized expert in specific regulatory domains including respiratory productsAt Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.**Diversity & Inclusion at Viatris**At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit**Sustainability at Viatris**Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visitAt Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Viatris is an Equal Opportunity Employer. #J-18808-Ljbffr
Director Respiratory Regulatory CMC page is loaded## Director Respiratory Regulatory CMClocations: Northern Cross, Dublin, Ireland: Sandwich, England, United Kingdom: United Kingdom Remote Office: Hatfield, England, United Kingdomtime type: Temps pleinposted on: Offre publiée il y a 2 joursjob requisition id: R5665371Mylan Pharma UK LimitedChez Viatris, nous envisageons la santé non pas telle qu'elle est mais telle qu'elle devrait être. Nous agissons avec courage et notre positionnement unique est source de stabilité dans un monde où les besoins en matière de santé sont en constante évolution. Viatris permet à chacun dans le monde entier de vivre en meilleure santé à chaque étape de sa vie. Via trois axes majeurs:*Accès*: En fournissant des médicaments de haute qualité et reconnus, quels que soient le lieu de résidence ou la situation de chaque patient.*Leadership*: En favorisant l’évolution de nos activités de façon durable et le développement de solutions innovantes pour améliorer la santé des patients.*Partenariat*: En valorisant notre expertise collective afin de donner accès à tous à nos produits et services.Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.**The Role & What You Will Be Doing**Every day, we rise to the challenge to make a difference and here’s how the **Director Respiratory Regulatory CMC** role will make an impact:* Cultivates sustainable & effective relationships across a network of stakeholders, partners and customers to drive and establish aligned approaches to regulatory strategies and/or policies.* Uses technical and scientific knowledge in the preparation and analysis of global CMC submission documentation and maintenance of product compliance and management of CMC change control. Guides preparation of CMC submission documentation where assigned* Serves as a liaison with regulatory agencies for specific topics and providing oversight for the fulfillment of agency commitments and providing responses to agency queries. Responsibilities include the lead in preparations and interactions for regulatory authority meetings* Manages, leads and contributes significantly to the respiratory portfolio, individual projects and initiatives within cross-functional project teams.* Participates, as required, in pharmaceutical industry conferences or serves externally as a representative to pharmaceutical trade group advisory committees relevant to CMC functions. Monitor the external competitor and regulatory environment and build knowledge into project strategies.* Performs other duties or equivalent duties for other product types as assigned* Serves as the primary reviewer of global CMC strategic plans and documentation/submissions for the assigned products (primarily within the respiratory product portfolio)**About Your Skills & Experience**For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:* Mandatory hands-on CMC authoring experience (initial registrations or post-approval variations)* Mandatory hands-on experience in Regulatory CMC for respiratory/inhaled products* High level of knowledge of development & commercial activities and cGMP’s to assess technical, scientific & regulatory merits of CMC information, commitments and data to lead teams and/or complex projects. Specific knowledge in development and life cycle management of respiratory/inhaled products is highly preferred* Extensive technical, functional, and industry knowledge in shaping project strategy, reducing regulatory burden & improving regulatory flexibility across global markets and diverse therapeutic areas. Independently capable of executing activities related to complex projects across all aspects of drug development and commercial manufacturing product lifecycle. Specific knowledge in development of respiratory/inhaled products or other combination product types with similar complexity is highly preferred* Advanced understanding of current and emerging regulatory requirements & expectations, criteria for submission & approval globally, & experience in leading negotiations and interactions with regulatory authorities for projects and/or policy initiatives.* Possesses sound understanding of business expectations across partner lines, with proven ability to partner successfully with other Regulatory functions, Manufacturing & Supply Chain, Quality, Safety, Medical, Commercial, Legal and senior stakeholders to achieve objectives.* Advanced skills in written & oral communications (mandatory).* Computer literacy with Microsoft Office Suite and Documentum-based applications.* Prior experience managing projects and matrixed teams and/or serving as a people manager* Ability to participate in interactions with regulatory authorities to respond to requests either directly or in conjunction with Regulatory Affairs personnel.* Demonstrated commitment & dedication to scientific & regulatory integrity & quality compliance.* Ability to engage in the external regulatory and pharmaceutical environment.* Proven ability to deliver to time, cost and quality standards* Demonstrated strategic thinking and ability to integrate strategies into actionable plans* Demonstrated experience serving as a Subject Matter Expert in specific relevant disciplines or as a recognized resource for specific pharmaceutical science projects and/or specialized expert in specific regulatory domains including respiratory productsAt Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.**Diversity & Inclusion at Viatris**At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit**Sustainability at Viatris**Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visitChez Viatris, nous proposons des salaires compétitifs, des bénéfices et un environnement inclusif au sein duquel vous pouvez mettre à profit votre expérience, vos perspectives et vos compétences pour aider à avoir un impact positif sur la vie des autres.Viatris est une entreprise mondiale de services de santé créée en 2020 par la combinaison de Mylan et Upjohn, une division héritée de Pfizer. En intégrant les atouts de ces deux entreprises, y compris notre main-d’œuvre mondiale d’environ 45 000 personnes, nous visons à offrir un accès accru à des médicaments #J-18808-Ljbffr
Director, Global Regulatory Strategist -Allergy/Cardiovascular portfolio page is loaded## Director, Global Regulatory Strategist -Allergy/Cardiovascular portfoliolocations: Northern Cross, Dublin, Ireland: Hatfield, England, United Kingdom: Inverin, County Galway, Irelandtime type: Tiempo completoposted on: Publicado hace 2 díasjob requisition id: R5665379McDermott Laboratories LimitedEn VIATRIS, vemos la atención médica no como es, sino como debería de ser. Actuamos con valentía y estamos en una posición única para ser una fuente de estabilidad en un mundo de necesidades de atención médica en constante evolución.Viatris ayuda a las personas de todo el mundo a vivir de manera más saludable en cada etapa de la vida.Lo hacemos a través de:Acceso – suministrando medicamentos de confianza y de alta calidad independientemente de la geografía o las circunstancias;Liderazgo – promoviendo operaciones sostenibles y soluciones innovadoras para mejorar la salud del paciente;Colaboración – aprovechando nuestra experiencia común para conectar a las personas con productos y servicios.Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.**The Role & What You Will Be Doing**Every day, we rise to the challenge to make a difference and here’s how the **Director, Global Regulatory Strategist** **role will make an impact.**The **Director, Global Regulatory Strategist** is a senior level position, recognized as an expert forglobal regulatory strategy in support of the Viatris Allergy/Cardiovascular portfolio.Key responsibilities for this role include: * Use innovative regulatory approaches and provide strategic regulatory guidance for assigned projects/products. Develop and implement regulatory strategies, integrating inputs from regulatory team and cross functional partners to build globally aligned regional regulatory strategies. Strategies should be in alignment with business objectives and key stakeholders/partner lines.* Manage the preparation and submission of correspondence and applications to regulatory agencies. Organize, lead, or participate in meetings with regulatory agencies, as appropriate. Ensure quality expectations are met for all submissions and Health Authority interactions.* Direct and/or indirect liaison with Health Authorities (in conjunction with Regulatory Country partners to facilitate the prompt review and approval of applications, supplements/variations, and commitments).* Developing Global/Regional regulatory strategies and implementation plans for Allergy and Cardiovascular complex projects/products including novel, product enhancement and post approval products; Ensuring regulatory contributions achieve the objectives in the strategy, meet agreed standards, while optimizing overall project delivery time and probability of a successful outcome.* Providing regulatory input to clinical development programs, risk/benefit assessments and for target label development.* Ensuring an aligned regulatory position is reached and communicated for all key issues for assigned projects/products, and that these regulatory positions supporting the business are championed, communicated, and executed on time to the required quality standards.* Serving as a member of the Product Labelling Team to contribute to the development and update of the CCDS and contribute to the development and maintenance of local labels, as appropriate.* Cultivate sustainable and effective relationships across a network of stakeholders, partners and customers to drive and establish aligned approaches to regulatory strategies and/or policies.* Ensuring regulatory plans are monitored, progress is communicated to Senior Management and any risks (from emerging technical data, changing internal objectives or external impacts) are mitigated.* Direct activities to ensure the required documentation is prepared to a high standard and that all regulatory requirements and/or commitments are met for obtaining Marketing Authorizations. Author sections of the dossiers, as applicable.* Developing and maintaining constructive working relationships with Health Authority contacts. Organize, lead or participate in meetings with regulatory agencies, as appropriate. Ensure quality expectations are met for all submissions and Health Authority interactions.* Work closely with other Regulatory team members to develop and ensure adherence to consistent and appropriate processes, systems, working practices, shared learnings and quality standards.* Understanding current global and regional evolving regulations and guidelines with the ability to assess these requirements' impact on products/projects. Using strong experience and examples, where appropriate, to influence the evolving regulatory environment through Health Authority engagement, partners and trade associations.**About Your Skills & Experience*** A higher degree, master’s or equivalent, is preferred.* Extensive regulatory experience within a Global Regulatory Affairs Strategy position with hands-on authoring experience (initial registrations or post-approval variations) -* Elevated level of knowledge of development & commercial activities to assess clinical, scientific & regulatory merits of information, commitments and data to lead teams and/or complex projects, with a focus on Allergy and Cardiovascular products.* Extensive clinical and industry knowledge in shaping project strategy, reducing regulatory burden & improving regulatory flexibility across global markets and diverse therapeutic areas. Independently capable of executing activities related to complex projects across all aspects of drug development and commercial manufacturing product lifecycle. Knowledge of Global applications for applications for Allergy and Cardiovascular products and product development an advantage.* Advanced understanding of current and emerging regulatory requirements & expectations, criteria for submission & approval globally, & experience in leading negotiations and interactions with regulatory authorities for projects and/or policy initiatives.* Possesses sound understanding of business expectations across partner lines, with proven ability to partner successfully with other Regulatory functions, Clinical, Non-Clinical, Safety, Medical, Commercial, R&D, Legal and senior stakeholders to achieve objectives.* Allergy and Cardiovascular therapeutic areas an advantage.**Benefits at Viatris**At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Some of our benefits include the following on top of a competitive salary:* Excellent career progression opportunities* Work-life balance initiatives* Bonus scheme* Health insurance* Pension**Diversity & Inclusion at Viatris**At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit**Sustainability at Viatris**Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live #J-18808-Ljbffr
