Regulatory CMC Associate Director – Pharma
Germany
Full Time
1 week ago
No Sponsorship
About this role
Role Overview
- Lead the EU CMC strategy for multiple clinical programs
- Translate technical changes into regulatory robust strategies
- Develop solutions for comparability, specifications and process changes
- Identify regulatory risks early and define pragmatic mitigation measures
- Lead CMC activities for clinical trial applications and amendments
- Prepare structured, high-quality submission documentation
- Design strategies for communications with regulatory authorities
- Prepare for and support interactions with EU authorities
- Ensure regulatory compliance of external manufacturing partners
- Work closely with Quality and technical functions
- Actively monitor regulatory developments in the CMC space
- Contribute to the advancement of regulatory standards within the company
Requirements
- Degree in a life science, pharmacy or a related discipline
- Minimum 6 years’ experience in Regulatory Affairs CMC for biologics or ATMPs
- Solid knowledge of EU regulations and GMP requirements
- Experience with clinical trial applications and interactions with authorities (including Scientific Advice)
- Ability to work independently in complex, dynamic environments
- Structured, pragmatic and solution-oriented mindset
- High level of personal ownership and strong teamworking skills
- Excellent English; German is an advantage
Benefits
- Strategic role within an international environment
- Flexible working model with significant autonomy
- Work on innovative projects with a modern pipeline
- Attractive compensation and additional benefits