Title: Manager Regulatory Strategy-International (Oncology)
Location: Basel, Switzerland
The Role:
- Provide regulatory support to the Director, Regulatory Affairs-Regional Regulatory Strategist, - EU & International.
- This is a newly created role intended for a forward looking, creative and agile regulatory manager able to anticipate and address the challenges involved in supporting the Health Agency interactions in EU and International markets
- The Manager will provide regulatory clinical support for the Oncology Therapeutic Area. Their support includes but is not limited to requesting Scientific Advice meetings at the national and Pan-EU level, managing the marketing authorisation applications in EU and International markets, and other regulatory submissions (orphan drug designations, paediatric plans, PRIME, DSURs, MAA, etc.
Responsibility:
- Develop and contribute to content, format and accountability for regulatory submissions and related supplements and amendments, including National Scientific Advice (NSA) meeting requests.
- Work with the Director, Regulatory Affairs- Regional Regulatory Strategist - EU & International - Oncology, Head of Oncology Regulatory Strategy, , the Project teams, the RA International team.
- Responsible for coordinating aspects of regulatory submissions relevant to assigned projects or programs
- Identify and assess regulatory risks for assigned projects or programs
- Contact relevant regulatory agencies relevant to assigned projects or programs, as appropriate
- Ability to work both independently and within project teams, committees, etc. to achieve group goals
- Accountable for tracking, following up and archiving correspondence, regulatory commitments, and queries from International Health Agencies
Requirements:
- Degree in Life Science or related discipline, advanced degree preferred (PharmD, MSc, PhD)
- 5+ years of experience in the pharmaceutical industry.
- Strong knowledge of current EU and International regulations related to the clinical, nonclinical, and CMC development
