Regulatory Affairs Associate Director – Clinical Lead
Germany
Full Time
6 days ago
No Sponsorship
Key skills
CollaborationRemote Work
About this role
Role Overview
- Manage the EU regulatory strategy across all clinical development phases
- Own programs from first-in-human through to market approval
- Lead Scientific Advice and strategic communications with regulatory authorities
- Translate complex requirements into clear regulatory action plans
- Oversee clinical trial applications (CTAs) and major amendment procedures
- Identify regulatory risks early and define concrete mitigation measures
- Ensure high-quality and consistent submission documentation
- Proactively shape regulatory strategies in the ATMP space
- Work closely with cross-functional teams
- Help prevent regulatory risks in late-stage development
Requirements
- Degree in a natural science, pharmacy, or Regulatory Affairs
- At least 6 years’ experience in Regulatory Affairs for biopharma or ATMPs
- Experience in EU regulatory strategy for clinical development programs
- Experience with Scientific Advice procedures and authority interactions
- Solid knowledge of CTA submissions and lifecycle management
- Ability to make sound decisions in complex situations
- Structured, solution-oriented and pragmatic working style
- Experience in cross-functional collaboration
- Excellent English; German is an advantage
Benefits
- Strategic role within an international environment
- Flexible working model including 100% remote work
- Option to be based within Germany
- Work on innovative projects with a modern pipeline
- Attractive compensation and additional benefits