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Clinical Regulatory Director
Vor 4 Tagen
Clinical Regulatory Director
*Based in Munich, Germany*
This role supports cross-functional development teams engaged in innovative drug development (including small molecules, biologicals, and ATMPs) at all stages - from research through clinical development to MAA, NDA/BLA submission.
Responsibilities
- Provide strategic regulatory guidance to project teams.
- Oversee clinical development within project teams.
- Plan and execute the global regulatory development plan.
- Develop and manage the global agency interaction strategy.
Qualifications
- Advanced degree in life sciences, medicine, or veterinary medicine.
- Minimum of 10 years of experience in pharmaceutical development.
- Hands-on experience in strategic clinical development and regulatory strategy (experience in people management alone is insufficient).
- Preferably experienced across various pharmaceutical companies and/or regulatory authorities.
- Strong understanding and communication of complex development scenarios.
- Strategic thinker, solution-oriented.
- Capable of working independently, managing multiple tasks under time constraints, with excellent prioritization skills.
- Familiarity with both EU and US regulatory procedures is preferred but not required.
Additional Information
- Based in Munich, Germany, with office presence required at least three days per week.
- The company offers a dedicated relocation package, including local support for accommodation, school placements, and bureaucratic processes.
- The role supports further skill development through exposure to diverse, cutting-edge scientific projects, rather than climbing hierarchical managerial levels.
- This position does not involve client acquisition.
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