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
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