Director Global Regulatory Affairs | Pharmacist (m/w/d)

BioNTech SE

Mainz am Rhein, Rheinland-Pfalz, Deutschland
Published Jul 16, 2025
Full-time
No information

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

English (Fluent)

Additional

  • Not specified