Regulatory Affairs Senior Specialist

4 weeks ago

Dublin, Dublin City, Ireland Xeolas Full time

Dublin, Ireland - Permanent Full Time Role

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 Regulatory Affairs Senior Specialist as we expand.

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.

Reporting To

Manager Regulatory Affairs

Requirements
  1. Preparation and maintenance of high-quality dossiers (marketing authorisation applications/ Response to Health authority questions/ post-approval submissions).
  2. Submission of CPP/ Manufacturing authorisation requests to HPRA/MHRA.
  3. Review of data intended for submission and advise regarding any deficiencies or issues.
  4. Ensure on-time submissions for all quality/ safety related changes for assigned projects.
  5. Preparation and submission of translated texts to EU/Non-EU countries.
  6. Update of databases and systems for all products (in-line with current SOPs).
  7. Liaise with 3rd parties (where required) to establish effective communication and relationships in order to progress regulatory activities.
  8. Liaise closely with Business Development, Product Launch, Artwork, Supply Chain and Quality colleagues to ensure alignment in all initiatives.
  9. 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.
  10. 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.
  11. Embrace Xeolas values and behaviour.
  12. Support the Xeolas business by participating in project teams to support departmental initiatives.
  13. On an ad hoc basis, carry out additional tasks on behalf of Regulatory Affairs Manager.
Key Skills / Experience Requirements

For this role, we're looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

  1. Masters/ Bachelor's degree or equivalent in Science/Technology/ Pharmacy.
  2. Minimum 5 years of Experience in Regulatory.
  3. Capable of understanding health authority expectations for pharmaceuticals for EU/US/ROW regions.
  4. Must possess organization skills, time management skills and attention to detail.
  5. Excellent critical thinking and problem-solving abilities.
  6. Strong interpersonal and communication skills.
  7. Experience in dealing with multiple stakeholders, both internal and external.
Apply for this Job

Please send a cover letter and your CV to

#J-18808-Ljbffr

  • Urgent Search Regulatory Affairs Senior Specialist

    4 weeks ago

    Dublin, Dublin City, Ireland Xeolas Full time

    Dublin, Ireland - Permanent Full Time RoleXeolas 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 Regulatory Affairs Senior Specialist as we expand.Overall Role...

  • Senior Specialist, Regulatory Affairs

    3 weeks ago

    Dublin, Dublin City, Ireland West Pharmaceutical Services Full time

    Senior Specialist, Regulatory AffairsRequisition ID:71195Date:Sep 3, 2025Location:Dublin, Leinster, IEDepartment:Regulatory AffairsDescription:This is a hybrid position, 3 days a week onsite in our Dublin location.At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a...

  • Director of Regulatory Affairs

    4 weeks ago

    Dublin, Dublin City, Ireland Morgan Prestwich - Life Science & Healthcare Executive Search Full time

    OverviewOur client is a leading Rare Disease biopharmaceutical company committed to advancing innovative treatments to improve patient outcomes. Their mission is to transform care by delivering cutting-edge therapies while fostering strong scientific engagement with healthcare professionals and researchers.Our client is seeking a highly experienced Director...

  • Global Regulatory Affairs Associate Director

    3 weeks ago

    Dublin, Dublin City, Ireland Novartis Ireland Full time

    Global Regulatory Affairs Associate Director (Senior Global Program Regulatory Manager)Join to apply for the Global Regulatory Affairs Associate Director (Senior Global Program Regulatory Manager) role at Novartis IrelandGlobal Regulatory Affairs Associate Director (Senior Global Program Regulatory Manager)4 days ago Be among the first 25 applicantsJoin to...

  • Head of Ireland Regulatory Affairs, Vice President, Hybrid

    4 weeks ago

    Dublin, Dublin City, Ireland State Street Full time

    Head of Ireland Regulatory Affairs, Vice President, HybridState Street is hiring for the Head of Ireland Regulatory Affairs, Vice President, Hybrid role. This position is based in Ireland with hybrid work options.OverviewThe Head of Ireland Regulatory Affairs is responsible for driving the strategic relationship with the Central Bank of Ireland (CBI). This...

  • Senior Director, Global Regulatory Affairs Liaison – Pediatric Center of Excellence

    4 weeks ago

    Dublin, Dublin City, Ireland Gilead Full time

    Senior Director, Global Regulatory Affairs Liaison – Pediatric Center of ExcellenceJoin to apply for the Senior Director, Global Regulatory Affairs Liaison – Pediatric Center of Excellence role at Gilead.comSenior Director, Global Regulatory Affairs Liaison – Pediatric Center of Excellence3 days ago Be among the first 25 applicantsJoin to apply for the...

  • Sr Mgr Regulatory Affairs

    4 weeks ago

    Dublin, Dublin City, Ireland Regeneron Ireland DAC Full time

    At Regeneron, we're advancing science and medicine to improve lives.We're seeking a talented Regulatory Affairs Manager to join our team and play a pivotal role in supporting EU regulatory activities for oncology drug development.This is your chance to contribute to groundbreaking clinical development programs while collaborating with global experts and...

  • Head of Ireland Regulatory Affairs, Vice President, Hybrid

    4 weeks ago

    Dublin, Dublin City, Ireland State Street International (Ireland) Ltd Full time

    Who are we looking for Head of Ireland Regulatory Affairs is responsible for driving the strategic relationship with the Central Bank of Ireland (CBI) by: building effective relationships with supervision teams; generating insight into the regulator's supervision strategy and its implications for State Street; providing insight into areas of focus in...

  • Political Affairs and Communications Specialist

    4 weeks ago

    Dublin, Dublin City, Ireland Acquired Brain Injury Ireland Full time

    Political Affairs and Communications SpecialistJoin to apply for the Political Affairs and Communications Specialist role at Acquired Brain Injury IrelandPolitical Affairs and Communications SpecialistJoin to apply for the Political Affairs and Communications Specialist role at Acquired Brain Injury IrelandGet AI-powered advice on this job and more exclusive...

  • Director, Regulatory Affairs CMC

    4 weeks ago

    Dublin, Dublin City, Ireland Cytokinetics Full time

    Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of...