Director Global Regulatory Affairs | Pharmacist (m/w/d)
BioNTech SE
Job Summary
As the Director Global Regulatory Affairs, you will serve as the Global Regulatory Lead for assigned development projects, taking charge of defining and executing comprehensive regulatory strategies, including interactions with health authorities. Your role involves developing the compelling storyline for regulatory applications and dossiers throughout the product development lifecycle, up to marketing authorization. You will coordinate the preparation, writing, and review of critical documents, contribute to optimizing regulatory processes, and supervise external vendors. This position is ideal for a seasoned professional with extensive experience in regulatory affairs, particularly within the development of antibody- and ADC-based cancer therapies, who possesses a strong understanding of drug development and a solution-oriented mindset.
Required Skills
Education
University degree in natural sciences (medicine, pharmacy, chemistry, biotechnology, biology or equivalent)
Experience
- 9+ years of working experience in Regulatory Affairs in relevant roles/positions
- Experience in the development of antibody- and ADC-based cancer therapies
- Experience in regulatory strategy planning
- Proven ability to plan, coordinate and lead activities
- Experience with novel-novel combination therapy and companion diagnostic development (a plus)
Languages
Additional
- Not specified
More Jobs from BioNTech SE
Histology Technical Assistant | MTLA (m/w/d)
Jul 15, 2025
As a Histology Technical Assistant at BioNTech in Mainz, you will play a crucial role in processing ...
Site Head, Clinical Manufacturing Individualized Cancer Vaccines | Pharmacist (m/w/d)
Jul 15, 2025
This pivotal role seeks a highly experienced and motivated Site Head to lead the clinical manufactur...
Site Head Commercial Manufacturing Individualized Cancer Vaccines | Pharmacist (m/w/d)
Jul 15, 2025
This pivotal role seeks an experienced Site Head to lead the commercial manufacturing site for indiv...