Associate Director Regulatory Affairs

By | Februar 11, 2021
  • Überall

Job title: Associate Director Regulatory Affairs

Company: Ageneo Life Science Experts

Job description: We’re looking for a candidate to fill this position in an exciting company.

  • You will develop and implement regulatory strategies from preclinics up to registration
  • You will ensure compliance with applicable regulations in an international setting
  • You will oversee the preparation of regulatory documents, protocols, etc.
  • You will lead and coordinate submissions, INDs, CTAs, MAA/BLAs etc.
  • You will coordinate and interface with legal authorities and support your team during the preparation and execution of meetings with FDA, EMA, and other regulatory agencies
  • You will impact the regulatory strategies in different projects, development stages and settings
  • You will manage CROs and other external partners
  • You will interface with internal teams in order to develop and improve processes, ensuring the compliance throughout all process phases
  • You will manage and develop your team and be their trainer and coach
  • Degree in natural sciences (Master or PhD), ideally in biology, biotechnology, pharmaceutical sciences or comparable
  • Profound knowledge and experience in regulatory CMC for biologics
  • Many years of professional experience in a pharmaceutical resp. bio-pharmaceutical company
  • At least five years of experience in a responsible role in regulatory affairs
  • Thorough knowledge of the drug development process and experience with submission processes along different development phases
  • Excellent communication and presentation skills
  • Leadership experience and talent development experience is preferable
  • Excellent English language skills
  • Work permit for Germany is mandatory

Expected salary:

Location: München, Bayern

Job date: Thu, 11 Feb 2021 08:06:18 GMT

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