Regulatory Affairs Specialist ABOUT XEOLAS Xeolas is an Irish-owned speciality Pharmaceutical company located in Dublin, Ireland with 70+ employees. We develop and manufactureinnovativepatient friendly pharmaceutical products for international markets. We are now seeking an experiencedRegulatory Affairs Specialistas weexpand. OVERALL ROLE OBJECTIVE The Regulatory Affairs Specialist will report directly to the Regulatory Affairs Manager and be involved in all aspects of regulatory affairs of the company including existing licensed products as well as products under development. SPECIFIC RESPONSIBILITIES Reporting To: Manager Regulatory Affairs REQUIREMENTS: Preparation and maintenance of high quality dossiers (marketing authorisation applications/ Response to Health authority questions/ post-approval submissions). Submission of CPP/ Manufacturing authorisation requests to HPRA/MHRA Review of data intended for submission and advise regarding any deficiencies or issues. Ensure on-time submissions for all quality/ safety related changes for assigned projects. Preparation and submission of translated texts to EU/Non-EU countries Update of databases and systems for all products (in-line with current SOPs) Liaise with 3rd parties (where required) to establish effective communication and relationships in order to progress regulatory activities. Liaise closely with Business Development, Product Launch, Artwork, Supply Chain and Quality colleagues to ensure alignment in all initiatives. Advise management of the status and progress of assigned projects identifying potential problems or delays, and possible solutions, as they occur and maintain a current status report for these projects. Maintain an awareness of regulatory requirements (including legislation, guidelines, industry best practice, and through liaison with competent Authorities) and use this information to optimise departmental procedures and processes and to ensure Health Authority requirements and Regulatory Compliance are maintained. Embrace Xeolas values and behaviour Support the Xeolas business by participating in project teams to support departmental initiatives. On an ad hoc basis, carry out additional tasks on behalf of Regulatory Affairs Manager. KEYSKILLS /EXPERIENCE REQUIREMENTS For this role, we're looking for a candidate who has an effective combination of the following qualifications, skills and experiences: Masters/ Bachelor's degree or equivalent in Science/Technology/ Pharmacy Minimum 4 years of Experience in Regulatory Capable of understanding health authority expectations for pharmaceuticals for EU/US/ROW regions. Must possess organization skills, time management skills and attention to detail. Excellent critical thinking and problem-solving abilities. Strong interpersonal and communication skills Experience in dealing with multiple stakeholders, both internal and external.
Regulatory Affairs Senior Specialist ABOUT XEOLAS Xeolas is an Irish-owned speciality Pharmaceutical company located in Dublin, Ireland with 70+ employees. We develop and manufactureinnovativepatient friendly pharmaceutical products for international markets. We are now seeking an experiencedRegulatory Affairs Senior Specialistas weexpand. OVERALL ROLE OBJECTIVE The Regulatory Affairs Senior Specialist will report directly to the Regulatory Affairs Manager and be involved in all aspects of regulatory affairs of the company including existing licensed products as well as products under development. SPECIFIC RESPONSIBILITIES Reporting To: Manager Regulatory Affairs REQUIREMENTS: Preparation and maintenance of high quality dossiers (marketing authorisation applications/ Response to Health authority questions/ post-approval submissions). Submission of CPP/ Manufacturing authorisation requests to HPRA/MHRA Review of data intended for submission and advise regarding any deficiencies or issues. Ensure on-time submissions for all quality/ safety related changes for assigned projects. Preparation and submission of translated texts to EU/Non-EU countries Update of databases and systems for all products (in-line with current SOPs) Liaise with 3rd parties (where required) to establish effective communication and relationships in order to progress regulatory activities. Liaise closely with Business Development, Product Launch, Artwork, Supply Chain and Quality colleagues to ensure alignment in all initiatives. Advise management of the status and progress of assigned projects identifying potential problems or delays, and possible solutions, as they occur and maintain a current status report for these projects. Maintain an awareness of regulatory requirements (including legislation, guidelines, industry best practice, and through liaison with competent Authorities) and use this information to optimise departmental procedures and processes and to ensure Health Authority requirements and Regulatory Compliance are maintained. Embrace Xeolas values and behaviour Support the Xeolas business by participating in project teams to support departmental initiatives. On an ad hoc basis, carry out additional tasks on behalf of Regulatory Affairs Manager. KEYSKILLS /EXPERIENCE REQUIREMENTS For this role, we're looking for a candidate who has an effective combination of the following qualifications, skills and experiences: Masters/ Bachelor's degree or equivalent in Science/Technology/ Pharmacy Minimum 7 years of Experience in Regulatory Capable of understanding health authority expectations for pharmaceuticals for EU/US/ROW regions. Must possess organization skills, time management skills and attention to detail. Excellent critical thinking and problem-solving abilities. Strong interpersonal and communication skills Experience in dealing with multiple stakeholders, both internal and external.
Pharmacovigilance Senior Specialist Location: Ireland Department: Pharmacovigilance Reports To: RA Manager Company Overview Xeolas is an Irish-owned speciality Pharmaceutical company located in Dublin, Ireland with 70+ employees. We develop and manufacture innovative patient friendly pharmaceutical products for international markets. We are now seeking an experienced Pharmacovigilance Senior Specialist to join our expanding team in Ireland. This role is ideal for an experienced PV professional looking to take on strategic responsibilities and contribute to the continued excellence of pharmacovigilance operations. Role Summary As a Pharmacovigilance Senior Specialist, you will be responsible for overseeing and executing a wide range of pharmacovigilance activities, ensuring compliance with global regulatory standards. You will provide expert guidance on safety case management, regulatory documentation, and inspection readiness, while also mentoring team members and supporting client relationships. Key Responsibilities Safety Case Management: Oversee the processing and reporting of Individual Case Safety Reports (ICSRs). Ensure accurate and timely maintenance of safety databases. Process PV events, and product quality complaints in line the organisations operating procedures Perform mailbox triage and management, case processing, reconciliation, query management and other tasks to ensure compliance with pharmacovigilance procedures. Regulatory Documentation: Draft, review, and finalize Pharmacovigilance Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Ensure documentation is completed in accordance with regulatory timelines and client expectations. Compliance & Quality Systems: Ensure adherence to internal quality systems and global pharmacovigilance regulations. Lead and support audits and inspections conducted by regulatory authorities. Develop and implement corrective and preventive actions (CAPAs) as needed. Client & Team Collaboration: Act as a key point of contact for clients, providing expert PV advice and support. Mentor and guide junior PV staff, fostering professional development and knowledge sharing. Continuous Improvement: Stay current with evolving regulatory requirements and industry best practices. Contribute to the enhancement of PV processes, SOPs, and systems. Qualifications & Experience Bachelors degree in Life Sciences, Pharmacy, Medicine, or a related field (advanced degree preferred). Minimum of 5 years experience in pharmacovigilance within the pharmaceutical or regulatory services industry. Strong understanding of EU and global PV regulations and guidelines. Proven experience in case processing, safety database management, and regulatory submissions. Demonstrated ability to manage audits and inspections effectively. Excellent communication, organizational, and problem-solving skills. Ability to work independently and collaboratively in a fast-paced environment.
