Associate Director Regulatory Affairs

By | Februar 11, 2021
  • Überall

Job title: Associate Director Regulatory Affairs

Company: Constares GmbH

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

  • Define RA strategy for Formycon’s development projects with main focus on US and Europe and lead its implementation
  • Ensure timely preparation of regulatory documents (e.g. Briefing Books, IMPD/IND; BLA/MAA)
  • Guide cross-functional teams in defining the best strategy for each submission, their content and the contribution of each team member to their preparation
  • Lead and coordinate submissions, such as: INDs/CTAs, Briefing Documents for Health Authorities, PIP/PSP, MAA/BLAs etc.
  • Coordinate health authority interactions and support to prepare the team for meetings with FDA/EMA and other Regulatory Agencies
  • Maintain knowledge of global competitive landscape, regulatory environment, and regulations.
  • Manage regulatory CROs in charge of assigned work packages
  • Contribute to the continuous improvement of internal processes, maximizing opportunities for improvement while ensuring compliance to applicable regulations
  • Management responsibility for regulatory affairs team (>10 team members); develop, direct and coach direct reports
  • Compilation and maintenance of project, budget and capacity plans
  • Scientific background with master degree or PhD, preferably in biology, biotechnology, pharmaceutical sciences, chemistry or equivalent
  • At least 10 years pharmaceutical industry experience, including minimum 6 years in regulatory affairs.
  • Thorough knowledge of the drug development process with demonstrated experience in multiple development phases up to submission
  • Strong experience in regulatory CMC for biologics is a must; experience in clinical strategy and/or biosimilar experience is of advantage
  • Excellent written as well as presentation and communication skills in English
  • Strong leadership, talent management and networking skills
  • Entrepreneurial mindset
  • German work permit is mandatory

Expected salary:

Location: Krailling, Bayern

Job date: Thu, 11 Feb 2021 05:23:23 GMT

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