Associate Director Regulatory Affairs (m/f/d)

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Ansprechpartner
Dilsâd Babayigit
+49 (0)89 7263 210 – 00
babayigit@ageneo.de
Branche
Pharmazeutische Industrie
Berufsfeld
Regulatory Affairs
Region
Bavaria, Germany

DAS UNTERNEHMEN

For a leading bio-pharmaceutical company in Bavaria, we are currently looking for an Associate Director Regulatory Affairs (m/f/d). In this role, you will be responsible for both managing the regulatory affairs team of more than ten people and managing technically all regulatory-related projects and implement regulatory strategies. If you want to become part of a growing company with a great culture, we should get in contact. 

IHRE AUFGABEN

  • 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
  • ...

IHR PROFIL

  • 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

BENEFITS

  • high impact role 
  • excellent work and company culture 
  • flexibility and additional social benefits