You will be responsible for defining and implementing regulatory strategies from preclinical up to registration. You will also be responsible for ensuring compliance with applicable regulations and will contribute to out-licensing activities. Your role is key for defining development paths for our client's development projects. In this position you would report directly to the Director of Regulatory Affairs and Quality Management.
- Define RA strategy for 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, maximising 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