For one of our top Biopharma clients, we are looking for a Regulatory Affairs Liaison.
- Strategic and tactical input in development, post-approval and life cycle management of small/large molecules.
- Advise the Project Team on applicable regulatory issues.
- Develop and ensure effective implementation of regional regulatory strategy and tactics in support of the global development and life-cycle management plan.
- Liaison with Regulatory Agencies and Local Operating Companies - establish and maintain strong relationships with Regulatory Agencies and effectively negotiate with Regulatory Agencies on product specific labeling, study design, submissions content, and post-approval commitments.
- Act as primary contact with EMEA.
- Plan and develop briefing documents for meeting with Regulatory Agencies.
- Advise team on required documents and submission strategies in preparation of CTA.
- Manage submissions and advise team on required documents and submission strategies in preparation of MAAs
- University degree - medical or paramedical (pharmacy, biology, veterinary etc.) or equivalent by experience.
- Regulatory experience in drug development and commercialization of vaccines.
- Experience with EU regulatory procedures (CP, MRP, national) and knowledge of the regulatory environment, guidelines and practice of EMEA regions.
- Excellent knowledge of English.
- Freelance opportunity
- Remote working opportunity
- 20 - 25 hours (but more hours is possible)
- Start date: as soon as possible
For more info, please contact Isla Littlewood at +31 20 20 44 502 or firstname.lastname@example.org.