My client is looking for a Regional Brand Regulatory Manager to provide strategic and operational regulatory direction for the EU region and support to the Global Program Regulatory Director for programs or brands and line extensions through development, registration and approval/post approval. You will ensure the execution of European regulatory plans in line with global regulatory strategy.
It's a permanent position based in Basel, Switzerland.
Main skills and experience required
- Bachelors Degree in Life Science, Pharmacy or Medicine or equivalent, Masters or PhD degree preferred
- Fluency in English as a business language
- Strong knowledge of submission and approval processes in region.
- Experience leading regulatory submissions and approvals in regions.
- Experience in matrix environment or cross-functional teams.
- Experience in HA negotiations.
- Experience in a global/matrix environment in the pharmaceutical industry.
- Strong interpersonal, communication, negotiation and problem solving skills.
- Organizational awareness (e.g., interrelationship of departments, business priorities)
- Some years involvement in regulatory and drug/biologic development spanning activities in Phases I- IV in the following areas
1. Innovation in regulatory strategy.
2. Prior history with post-marketing/brand optimization strategies and commercial awareness preferred.
3. Involvement in dossier submissions and approvals.
4. HA negotiations
5. Drug regulatory submission and commercialization in region.
6. Proven ability to analyze and interpret efficacy and safety data.
7. Regulatory operational expertise.
This job was posted 30+ days ago, and has expired.
