MSAT Visual inspection lead page is loaded## MSAT Visual inspection leadlocations: Waterford: Val-de-Reuil: Le Trait: Marcy-l'Etoile: Frankfurt am Maintime type: Vollzeitposted on: Heute ausgeschriebentime left to apply: Enddatum: 26. April 2026 (Noch 18 Tage Zeit für Bewerbung)job requisition id: R2850616**MSAT Visual Inspection Lead*** *Location: Site based from Waterford, Val-De-Reuil, Le Trait, Frankfurt or other Drug Product Site in Sanofi*About the job**Our Team:**We are an R&D-driven, AI-powered biopharma company with one unwavering purpose: **to chase the miracles of science and improve people's lives.**Our deep understanding of the immune system — combined with an innovative and growing pipeline — enables us to invent medicines and vaccines that treat and protect millions of people worldwide. At Sanofi, we believe that progress is powered by people: bold thinkers, collaborative leaders, and passionate scientists who dare to push boundaries every day.**Join us. And help change the world.**This is a great opportunity to shape the future of Visual Inspection (VI) on a global scale.As the **Global MSAT Visual Inspection Lead**, you will be at the heart of Sanofi's injectable manufacturing excellence — driving the strategy, standardization, and innovation of visual inspection programs across a network of drug product sites in three Global Business Units (GBUs). You will lead a team of VI experts, champion cutting-edge inspection technologies and processes, and serve as the authoritative voice connecting Manufacturing Science, Analytics & Technology (MSAT) with Global Quality, Engineering, Procurement, and Business Strategy.This is more than a technical leadership role — it is a platform to **inspire teams, influence industry practices, and deliver meaningful impact for patients worldwide.****Main responsibilities:**• Lead the Global Visual Inspection program as MSAT authority, serving as a strategic partner in Sanofi's enterprise-wide VI strategy while aligning Global Quality, Global Engineering, Procurement, Business Strategy, and injectable manufacturing sites on all VI-related topics.• Build, lead, and develop a high-performing team of VI experts distributed across 8 sites, providing specialist support across the full Drug Product injectable network.• Drive global harmonization of VI strategy and implementation across Manual (MVI), Semi-Automated (SAVI), and Automated (AVI) inspection modalities for vials, pre-filled syringes, and cartridges.• Deliver expert technical guidance on defect classification, VI recipe optimization, particulate control, false reject rate reduction, robotics, and layered inspection technologies, ensuring holistic VI lifecycle management.• Lead the evaluation and acquisition of new VI lines and emerging technologies, ensuring full alignment with quality, regulatory, and operational requirements across the network.• Champion innovation and industry benchmarking by identifying cost-effective inspection solutions and actively engaging with PDA, Biophorum, A3P, and other industry bodies to define and disseminate best practices across the organization.• Ensure full regulatory compliance and good documentation practices while providing structured mentorship and knowledge transfer to develop VI capability across new and existing associates.**About you*** *Proven background in injectable manufacturing within a cGMP environment, with dedicated expertise in visual inspection and a track record of leadership and impact** *Demonstrated experience in transformation programs, technology transfer, validation, and manufacturing support**Qualifications** *Advanced degree in a scientific discipline** *Deep knowledge of GMP, CMC requirements, and current regulatory guidance and best practices in visual inspection, as defined by global health authorities** *Experience preparing and reviewing regulatory dossiers with direct health authority interactions**Skills & Competencies** *Exceptional leadership presence — able to inspire, influence, and align cross-functional and multicultural teams without direct authority** *Outstanding communication skills, with the confidence to engage senior stakeholders and represent Sanofi in external industry forums** *Proven ability to operate autonomously in complex, matrixed, and international environments**Operational & Language** *Fluency in English required; proficiency in an additional European language is a valued asset** *Flexibility to provide occasional off-shift support, remotely or on-site, as operational needs require*Diversity und Inklusion sind in den Grundwerten von Sanofi verankert und spiegeln sich in unserer Arbeitsweise wider. Wir respektieren die Vielfalt unserer Belegschaft in Hinsicht auf ihre Herkunft, Erfahrungen und Lebensweisen. Wir erkennen die Bereicherung, die diese Vielfalt birgt, und fördern Inklusion sowie eine Arbeitsumgebung, in der diese Unterschiede sich weiter entwickeln können, zur Stärkung des Lebens unserer Mitarbeiter, Patienten und Kunden. #J-18808-Ljbffr
MSAT Visual inspection lead page is loaded## MSAT Visual inspection leadlocations: Waterford: Val-de-Reuil: Le Trait: Marcy-l'Etoile: Frankfurt am Maintime type: Full timeposted on: Posted Todaytime left to apply: End Date: April 26, 2026 (18 days left to apply)job requisition id: R2850616**MSAT Visual Inspection Lead*** *Location: Site based from Waterford, Val-De-Reuil, Le Trait, Frankfurt or other Drug Product Site in Sanofi*About the job**Our Team:**We are an R&D-driven, AI-powered biopharma company with one unwavering purpose: **to chase the miracles of science and improve people's lives.**Our deep understanding of the immune system — combined with an innovative and growing pipeline — enables us to invent medicines and vaccines that treat and protect millions of people worldwide. At Sanofi, we believe that progress is powered by people: bold thinkers, collaborative leaders, and passionate scientists who dare to push boundaries every day.**Join us. And help change the world.**This is a great opportunity to shape the future of Visual Inspection (VI) on a global scale.As the **Global MSAT Visual Inspection Lead**, you will be at the heart of Sanofi's injectable manufacturing excellence — driving the strategy, standardization, and innovation of visual inspection programs across a network of drug product sites in three Global Business Units (GBUs). You will lead a team of VI experts, champion cutting-edge inspection technologies and processes, and serve as the authoritative voice connecting Manufacturing Science, Analytics & Technology (MSAT) with Global Quality, Engineering, Procurement, and Business Strategy.This is more than a technical leadership role — it is a platform to **inspire teams, influence industry practices, and deliver meaningful impact for patients worldwide.****Main responsibilities:**• Lead the Global Visual Inspection program as MSAT authority, serving as a strategic partner in Sanofi's enterprise-wide VI strategy while aligning Global Quality, Global Engineering, Procurement, Business Strategy, and injectable manufacturing sites on all VI-related topics.• Build, lead, and develop a high-performing team of VI experts distributed across 8 sites, providing specialist support across the full Drug Product injectable network.• Drive global harmonization of VI strategy and implementation across Manual (MVI), Semi-Automated (SAVI), and Automated (AVI) inspection modalities for vials, pre-filled syringes, and cartridges.• Deliver expert technical guidance on defect classification, VI recipe optimization, particulate control, false reject rate reduction, robotics, and layered inspection technologies, ensuring holistic VI lifecycle management.• Lead the evaluation and acquisition of new VI lines and emerging technologies, ensuring full alignment with quality, regulatory, and operational requirements across the network.• Champion innovation and industry benchmarking by identifying cost-effective inspection solutions and actively engaging with PDA, Biophorum, A3P, and other industry bodies to define and disseminate best practices across the organization.• Ensure full regulatory compliance and good documentation practices while providing structured mentorship and knowledge transfer to develop VI capability across new and existing associates.**About you*** *Proven background in injectable manufacturing within a cGMP environment, with dedicated expertise in visual inspection and a track record of leadership and impact** *Demonstrated experience in transformation programs, technology transfer, validation, and manufacturing support**Qualifications** *Advanced degree in a scientific discipline** *Deep knowledge of GMP, CMC requirements, and current regulatory guidance and best practices in visual inspection, as defined by global health authorities** *Experience preparing and reviewing regulatory dossiers with direct health authority interactions**Skills & Competencies** *Exceptional leadership presence — able to inspire, influence, and align cross-functional and multicultural teams without direct authority** *Outstanding communication skills, with the confidence to engage senior stakeholders and represent Sanofi in external industry forums** *Proven ability to operate autonomously in complex, matrixed, and international environments**Operational & Language** *Fluency in English required; proficiency in an additional European language is a valued asset** *Flexibility to provide occasional off-shift support, remotely or on-site, as operational needs require*# Pursue *progress*, discover *extraordinary*Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.Watch our and check out our Diversity Equity and Inclusion actions at ! #J-18808-Ljbffr
Eine biopharmazeutische Firma mit Sitz in Waterford sucht einen erfahrenen Global MSAT Visual Inspection Lead, der die globale Strategie für visuelle Inspektion leitet und ein Team von Experten aufbaut. Der ideale Kandidat hat umfangreiche Kenntnisse in der Herstellung von Injektabilia und der Einhaltung von cGMP-Richtlinien. Diese vielseitige Rolle umfasst die Leitung von Innovationsprogrammen, die Harmonisierung von Prozessen über mehrere Standorte und die Sicherstellung der regulatorischen Compliance. Das Unternehmen strebt nach Spitzenleistung in der Arzneimittelproduktion und fördert eine inklusive Arbeitsumgebung. #J-18808-Ljbffr
A leading biopharmaceutical company is seeking a Global MSAT Visual Inspection Lead based in Waterford. This role involves shaping the future of Visual Inspection on a global scale by leading a team and driving innovation across multiple drug product sites. The ideal candidate will have a strong background in injectable manufacturing, leadership experience, and a robust understanding of GMP regulations. This position offers the opportunity to influence industry practices and positively impact patient outcomes. #J-18808-Ljbffr
A leading biopharmaceutical company in Waterford, Ireland is seeking a Regulatory Affairs professional to manage product compliance, ensure timely submissions, and oversee quality documentation. The ideal candidate will have a degree in a related discipline and ideally 2+ years of experience in Regulatory Affairs or Quality Operations. Responsibilities include maintenance of regulatory dossiers, managing regulatory requests, and participating in inspections. Attractive perks include flexible working, onsite gym, and health support. #J-18808-Ljbffr
Location: Waterford Contract: FTC-23 Months About Waterford For more than 20 years, our Waterford team has continued to grow and diversify to serve patients around the world. Today, a team of almost 800 work together at a state‑of‑the‑art biopharmaceutical and medical device campus. Recognised through multiple local and national awards, Sanofi Waterford offers flexible working and access to a world of opportunities to grow your career at one location. As well as attractive benefits, the team enjoy access to an onsite gym and medical centre that underpin a strong commitment to health and wellbeing. About The Job The Regulatory Affairs Department in Waterford is responsible for managing products manufactured at Waterford from a regulatory perspective; ensuring submissions are submitted on time, assessing change controls and deviations and ensuring regulatory compliance. Our team is an energetic and close‑knit, helping each other where we can. Main Responsibilities Maintenance of, and variations to, CMC Dossier for assigned products. Support and manage all regulatory requests impacting site products including coordination of site expert responses to support GRA in conclusion of request for information (RFI) activities as a result of deficiency letters (DLs) received from respective Health Authorities (HAs). Assess the regulatory impact of proposed changes by site for assigned products. Review and approval of Quality documentation including (but not limited to): batch records; specifications; plans; protocols/technical reports; Standard Operating Procedures (SOPs), deviation assessments, and failure investigations for assigned products, as appropriate. Second RSO review for submission documentation. Track all site regulatory activities in real time within the site planning tracking tools. Monitor submission/approval status and track updates for assigned products. Participate in regulatory inspections/audits. Initial BLA/MAA authoring/coordination, as appropriate. Product Registration Renewals. Annual Reports e.g. US, Canada, Brazil. Periodic Quality Reviews (PQR). Contribute in project teams and provide regulatory guidance/ support. Takes ownership of product‑related meetings i.e. core meeting on site/meeting with GRA/RSO counterparts in sister sites. Regulatory or Dossier Compliance. Creation and maintenance of Overarching and Batch specific MARs/MCAs. Legalizations and notarization requests. Preparation of Site Master File (SMF). Maintenance of local site accreditations e.g. investigational manufacturing license (IMP), manufacturing license and GMP certification. Site Registrations & Renewals e.g. Foreign Manufacturing Registration (FMR). Distribution of approval notification to site. Document review (Veeva Vault). Ensure Quality tasks are completed in timely manner. About You Preferably 2 years+ in a similar role. Problem Solving, effective communication, critical thinking and time management. Experience of Regulatory Affairs, Manufacturing and/or Quality Operations, dealing with Health Authorities and working through corporate structure is desirable. Education: Degree in Science, Pharmacy or related discipline is essential. #J-18808-Ljbffr
(Senior) Medical Advisor, aT1D page is loaded## (Senior) Medical Advisor, aT1Dlocations: Readingtime type: Vollzeitposted on: Heute ausgeschriebentime left to apply: Enddatum: 19. April 2026 (Noch 18 Tage Zeit für Bewerbung)job requisition id: R2848716**Job Title: (Senior) Medical Advisor, aT1D****Location: Reading, UK****About This Role**Join the team transforming how healthcare is delivered for chronic and specialty conditions worldwide. In General Medicines, you’ll help drive meaningful outcomes in diabetes, transplant, and immunology - with the scale and urgency patients deserve.**About Sanofi**We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.**Main Responsibilities*** Develop and lead the medical strategy for autoimmune Type 1 Diabetes treatments in the UK and Ireland, ensuring our approach aligns with local healthcare needs and global objectives* Build strong partnerships with healthcare professionals, patient advocacy groups, and key opinion leaders to advance early detection and intervention in Type 1 Diabetes care* Collaborate closely with commercial and market access teams to demonstrate the clinical value of our therapies and support successful product launches* Generate and analyze medical evidence by working with research teams, attending scientific conferences, and translating insights into actionable strategies that improve patient outcomes* Create engaging educational content and digital tools for healthcare professionals, using multiple communication channels to share the latest scientific developments* Ensure all activities meet regulatory standards and ethical guidelines while managing early access programs for patients who could benefit from innovative treatments* Represent the UK and Ireland perspective in global clinical development discussions, influencing how new treatments are designed and tested**About You*** You have a strong background in Medical Affairs within the pharmaceutical or healthcare industry, with deep knowledge of Type 1 Diabetes, immunology, or related therapeutic areas.* You can develop and execute medical strategies that balance scientific rigor with practical implementation, and you're comfortable navigating ambiguity in a fast-evolving field.* You excel at building trust and collaboration with healthcare professionals, cross-functional teams, and external stakeholders to achieve shared goals.* You can translate complex scientific information into clear, compelling messages for diverse audiences, both in writing and presentations.* Fluency in English is essential**Why Choose Us*** Help shape the future of care for chronic and complex conditions like aT1D, Type 2 diabetes, transplant, and cardiovascular disease.* Drive meaningful impact at global scale: our medicines reach more than 100 million people each year.* Be part of a simpler, digital- and AI-powered business that’s rethinking how we work and engage with the world.* Turn bold ideas into breakthrough launches, with multiple new therapies planned through 2030 and beyond.* Stretch your career in a development playground, with opportunities across functions, regions, and the entire product lifecycle.* Work in a place that combines global scale with local expertise, backed by a strong culture of collaboration and shared purpose.* Contribute to innovations that improve outcomes, relieve pressure on healthcare systems, and expand access worldwide.* Join a team that’s not just transforming treatment - but asking what’s next, and making it real.* Join a workplace where diversity, equity, and inclusion are at the core, with Employee Resource Groups and leadership programs that celebrate every voice.We are proud to be a Disability Confident Employer, committed to offering interviews to candidates who request consideration under the Scheme and meet the minimum requirements for this role.If you have a disability and require adjustments for the interview process, please email us at diversity.recruitmentUKIE@sanofi.com. We are dedicated to ensuring an inclusive and supportive experience for all applicants.Visas for those who do not already have the right to work in the UK will be considered on a case by case basis according to business needs and resources.**Pursue Progress. Discover Extraordinary.**Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before.At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.#LI-EURDiversity und Inklusion sind in den Grundwerten von Sanofi verankert und spiegeln sich in unserer Arbeitsweise wider. Wir respektieren die Vielfalt unserer Belegschaft in Hinsicht auf ihre Herkunft, Erfahrungen und Lebensweisen. Wir erkennen die Bereicherung, die diese Vielfalt birgt, und fördern Inklusion sowie eine Arbeitsumgebung, in der diese Unterschiede sich weiter entwickeln können, zur Stärkung des Lebens unserer Mitarbeiter, Patienten und Kunden. #J-18808-Ljbffr
A leading biopharmaceutical company in Waterford is looking for a Regulatory Site Officer. This role involves managing regulatory submissions, ensuring compliance, and supporting regulatory requests. Candidates should have at least 2 years of relevant experience and a degree in Science, Pharmacy, or a related field. Benefits include flexible working and access to an onsite gym and medical centre. This position offers a unique opportunity to grow within a global company committed to health and wellbeing. #J-18808-Ljbffr
***Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail.******This job offer is accessible to all, regardless of gender.******Location:*** *Le Trait, France **Type:**Permanent,Full-time**About the job*The **Digital M&S GBU Cluster Head – Waterford & Le Trait** has the end-to-end accountability of Digital Delivery in front of Business management within their geographical/cluster perimeter. This includes driving strategic discussions with Business heads, applying Operational Excellence, Continuous Improvement and Value-added services delivery for the sites across several countries, multiple domains (Manufacturing, Shopfloor, Quality, Plant Supply Chain, Compliance, Cybersecurity, Site Infrastructure) and potentially multiple platforms (Pharma, Vaccines, Biologics, Injectables) within their perimeter.This role drives business impact and is there to strengthen business outcomes by leading and delivering reliable, valuable, innovative & cost-effective Digital services. This role also offers substantial global exposure and collaboration opportunities for career growth.The **Digital M&S GBU Cluster Head– Waterford & Le Trait** is also accountable to cascade the Digital M&S GBU strategies across all sites within the areas under their leadership and to deliver the roadmap composed of a collection of complex programs / projects**Scope:**This position manages multiple sites and global solutions for business processes and software’s. These include, but are not limited to, the following: Manufacturing Execution Systems (MES), Serialization platforms, Information Management tools, Statistical Analysis systems, Laboratory Information Management Systems (LIMS), ERPs, and Data Visualization platforms like Power BI.**Overview:**Provide leadership by guiding, instructing, and directing team members to achieve key results, including leading training sessions, workshops, and team performance reviews at the cluster or site level.Engage with key local, regional, cluster and global stakeholders to align and prioritize efforts, offering a platform for discussing local and global objectives with stakeholders and global Product Management.Coordinate and deliver efforts for the M&S site, implementing global solutions such as enterprise-wide MES implementations or global data analytics platforms.*Main responsibilities***60% Effort Coordination/Management*** Monitor the quantitative and qualitative achievements of the team; report results and provide feedback to management regarding team performance.* Orchestrate support of systems, computers, and hardware installations with third parties.* Coordinate contractors and execute site change controls, ensuring cross-functional team interaction.* Collaborate with security engineers to set up and maintain cybersecurity solutions for systems within scope, such as firewalls and intrusion detection systems.* Manage the projects between global and local organizations to ensure coherence and consistent use of systems.* Coordinate with local business users’ actions to design, implement, and maintain local and global systems.* Coordinate local activities in alignment with Digital Governance and Product Management teams, ensuring implementation of global directives and strategic objectives within their scope.* Prioritize team activities based on feedback from local and global stakeholders.**30% Strategy & Program/Project Management*** Deliver projects on time, on budget, on quality.* Engage with Business stakeholders to elaborate Digital M&S strategy within the cluster* Work closely with Sites Leadership Teams and Business Areas Leaders to validate the Digital M&S roadmap* Accountable for Digital budget at cluster and site level* Evaluate workload, solutions and sites readiness, budget and planning for rollout activities* Contribute to the various program’s governance, if and when needed. Contribute to analyze (feasibility, workload, cost) and to prioritize evolution requests raised by the sites, in collaboration with the business partners and the solutions centers* Deploy Sanofi Core Models as per agreed roadmap, in close collaboration with Business Areas and selected partners* Deliver local projects as per agreed roadmap* Support local digital initiatives and implement them with the support of Digital M&S team**10% Personal Development, Simplification & Innovation*** Actively drive your own Individual Development Plan and participate in mentoring or coaching others.* Simplify efforts of digital processes, policies, and tools, such as process automation or reducing manual reporting tasks.* Actively participate in and contribute to local, cluster, and global digital communities. Lead Site Digital transformation to develop talents and leverage their expertise beyond their current activities* Secure that Individual Development Plans of the team are in place and aligned with business needs and Digital M&S strategy* Drive actions to Simplify Digital processes, policies and tools implementation and enforcement* Lead actions with the Digital M&S team addressing all unmet needs to create a positive work environment* Possess a working knowledge of M&S and Digital M&S policies and procedures* Take an active role in promoting the digital transformation**Management Responsibility*** **Budget Responsibility**: **> 5M€ annually (projects and local LCM)*** **Headcount:** **directly 10-15 FTEs, indirectly 10-30 resources (including external services)*** **Number of active sites****: 2 between (SpeCare Waterford and Le Trait)*** **Number of users:** **Approximately 2,000-3,000*** Level of autonomy (low, medium, high): **High*** The role requires independent decision-making and leadership to drive results aligned with both site-level and global Digital objectives.* Compliance of the whole product line on GxP, BCP adoption and evolution on vital application*About you***Academic background:** Bachelor's or higher in Computer Engineering, Computer Science, System Analysis, Engineering, or related fields.**Professional experience and knowledge:*** Minimum 5–7 years of experience in Digital M&S solutions, including MES, Serialization, and Statistical Analysis systems.* Strong knowledge of business processes such as Label Printing, Electronic Work Instructions, Laboratory Information Management, and Data Visualization platforms like Tableau or Power BI.* Experience in Computerized Systems Validation and compliance frameworks (e.g., FDA, ISO standards, GAMP 5).* Project management expertise, preferably with certifications like PMP or Agile.* Proven ability to drive process improvement initiatives with a focus on innovation.* Excellent communication and presentation skills for both technical and non-technical stakeholders.**Leadership Capabilities**:* Steps beyond comfort zones* Foster a culture of creativity and innovation* Focuses energy on must-wins* Manages performance to high standards* Develops self and others* Recognizes and celebrates success.* Business understanding and Stakeholder engagement to execute the right strategy**Lead Competencies:*** **Act for Change**: Simplification, resilience & agility* **Cooperate transversally**: Business Orientation, holistic thinking, collaboration and information sharing* **Commit to Customers**: Executional excellence* **Result oriented****Other Core skills:*** Critical thinking and problem-solving skills* Coordination and management abilities* Innovation management* Strong communication skills* Sense of urgency**Languages**:* Proficiency in the local language – **FRENCH IS MANDATORY.*** Fluent in English (written and spoken) with demonstrated ability to communicate effectively in international, multilingual environments.* Ability to work in multilingual teams and adapt to cultural differences is important #J-18808-Ljbffr
Regulatory Site Officer page is loaded## Regulatory Site Officerlocations: Waterfordtime type: Full timeposted on: Posted Todaytime left to apply: End Date: April 10, 2026 (9 days left to apply)job requisition id: R2850268* *Location: Waterford** *Contract: FTC- 23 Months*## **About Waterford**For more than 20 years, our Waterford team has continued to grow and diversify to serve patients around the world. Today, a team of almost 800 work together at a state-of-the-art biopharmaceutical and medical device campus. Recognised through multiple local and national awards, Sanofi Waterford offers flexible working and access to a world of opportunities to grow your career at one location. As well as attractive benefits, the team enjoy access to an onsite gym and medical centre that underpin a strong commitment to health and wellbeing.## **About the job**The Regulatory Affairs Department in Waterford is responsible for managing products manufactured at Waterford from a regulatory perspective; ensuring submissions are submitted on time, assessing change controls and deviations and ensuring regulatory compliance.Our team is an energetic and close-knit, helping each other where we can.**Main responsibilities:*** Maintenance of, and variations to, CMC Dossier for assigned products.* Support and manage all regulatory requests impacting site products including coordination of site expert responses to support GRA in conclusion of request for information (RFI) activities as a result of deficiency letters (DLs) received from respective Health Authorities (HAs).* Assess the regulatory impact of proposed changes by site for assigned products.* Review and approval of Quality documentation including (but not limited to): batch records; specifications; plans; protocols/ technical reports; Standard Operating Procedures (SOPs), deviation assessments, and failure investigations for assigned products, as appropriate.* Second RSO review for submission documentation.* Track all site regulatory activities in real time within the site planning tracking tools.* Monitor submission/approval status and track updates for assigned products.* Participate in regulatory inspections/audits.* Initial BLA/MAA authoring/coordination, as appropriate.* Product Registration Renewals.* Annual Reports e.g. US, Canada, Brazil.* Periodic Quality Reviews (PQR).* Contribute in project teams and provide regulatory guidance/ support.* Takes ownership of product-related meetings i.e. core meeting on site/meeting with GRA/RSO counterparts in sister sites.* Regulatory or Dossier Compliance.* Creation and maintenance of Overarching and Batch specific MARs/MCAs.* Legalizations and notarization requests.* Preparation of Site Master File (SMF).* Maintenance of local site accreditations e.g. investigational manufacturing license (IMP), manufacturing license and GMP certification.* Site Registrations & Renewals e.g. Foreign Manufacturing Registration (FMR).* Distribution of approval notification to site.* Document review (Veeva Vault).* Ensure Quality tasks are completed in timely manner.## **About you*** Preferably 2 years+ in a similar role.* Problem Solving, effective communication, critical thinking and time management.* Experience of Regulatory Affairs, Manufacturing and/or Quality Operations, dealing with Heal Authorities and working through corporate structure is desirable.* Education: Degree in Science, Pharmacy or related discipline is essential.# Pursue *progress*, discover *extraordinary*Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.Watch our and check out our Diversity Equity and Inclusion actions at ! #J-18808-Ljbffr
