Director Global Regulatory Affairs Development Pipeline (Oncology) | Pharmacist (m/w/d)
BioNTech SE
Job Summary
This Director-level role involves acting as the Global Regulatory Lead for assigned oncology development projects, focusing on defining and executing comprehensive regulatory strategies from clinical development through to marketing authorization. Key responsibilities include defining strategies for interactions with national and supranational health authorities (such as the EMA, FDA, and PEI), developing the regulatory storyline for applications and dossiers, and coordinating the preparation and review of essential regulatory documents (e.g., MAAs, IBs). The ideal candidate must possess a university degree in natural sciences (medicine, pharmacy, chemistry, or equivalent) and at least 9 years of relevant regulatory experience, particularly in antibody- and ADC-based cancer therapies. A team-oriented, solution-focused mindset and business fluent English are essential for success in this global, high-impact position.
Required Skills
Education
University degree in natural sciences (medicine, pharmacy, chemistry, biotechnology, biology or equivalent)
Experience
- 9+ years of relevant experience in regulatory affairs
- Experience in the development of antibody- and ADC-based cancer therapies
- Experience in regulatory strategy planning
- Proven ability to plan, coordinate and lead activities
Languages
Additional
- Not specified
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