Associate Director, Regulatory Affairs

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Associate Director Global Regulatory Affairs Vaccines (m/f/x, 100%)
Janssen, a member of Johnson & Johnson’s Family of Companies, is recruiting for an Associate Director, Global Regulatory Affairs, supporting the Vaccines Therapeutic Area. The position is preferably based in Beerse (Belgium), Leiden (Netherlands), Bern or Zug (Switzerland). Other locations could also be considered.
Janssen develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in pulmonary hypertension, oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market – from patients to practitioners, from clinics to hospitals. For more information about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, please visit www.janssenpharmaceuticalsinc.com
Key Responsibilities include:
- Advise the GRL, GRT, Project Team and/or Regional Regulatory Leaders on applicable regulatory guidance and issues, project-specific regulatory issues, with focus on clinical regulatory aspects pertaining to vaccine development, registration and post-approval activities
- Drive understanding of global regulatory requirements, supporting the GRL
- Uses deep clinical and regulatory vaccine knowledge to develop efficient and innovative regulatory strategies, aiming for successful global vaccine development, registration, and obtain the most optimal label
- Ensure appropriate implementation of scientific advice / Regulatory Agency comments into development and life-cycle management activities
- Refine regulatory strategies as new data become available and re-assess throughout life as necessary
- Activities and responsibilities will include, but are not limited to, the facilitation and leading team meetings, representation of GRA at clinical, safety, labelling teams, provide input on governance recommendations
- Review of clinical and regulatory briefing materials, registration documentation and other internal briefing books, coordinate briefing/slide materials and contribute to the writing as deemed appropriate
- Provide input for developing and updating the TPP and the global label, including provide advice for local labels for clinical matters based on an understanding of the implications of regional regulatory strategy for the global label
- Provide input for the preparation of dossiers for submission to HA (MAA/BLA / IND/CTA/ variations)
- In collaboration with GRL and Regional and/or local Regulatory Leader, as applicable, support preparation of HA meetings, when appropriate lead meetings with Health Authorities (HA)
- In general acting as back-up for GRL as need be, depending on the occupancies of the GRL at a certain moment in time
Regulatory Input into Other Functions
- Work with the GRL and GRT to provide input for Target Label, Global label
- Provide feedback to Clinical Team, Safety team, other specific teams (commercial, market access, epi, regional regulatory subteams) as appropriate
- Work with GRL/ GRT to direct, manage and resolve any “issues” in specific team, as required with dedicated resources
- Collaborate with Regulatory Legal and Healthcare Compliance to address pertinent issues
- Review pertinent product/project-related communications, manuscripts and publications
- Conduct licensing evaluations (due diligences, as needed)