Clinical Regulatory Director

Vor 4 Tagen


Munich, Deutschland Leaman Life Sciences Vollzeit

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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