Specialist Global Regulatory Affairs | PTA (m/w/d)
BioNTech SE
Job Summary
This role is for a Specialist in Global Regulatory Affairs, supporting the Development Pipeline team in planning, preparing, and recording regulatory submissions. The specialist will work closely with Global Regulatory Leads (GRLs) to manage clinical trials and product development from a regulatory perspective, potentially acting as a primary contact for local regulatory partners. Key responsibilities include preparing regulatory documentation, ensuring good documentation practices, coordinating requests from local partners, and supporting responses to health authority inquiries. The position requires approximately 3 years of experience in Regulatory Affairs, strong organizational skills, and the ability to thrive in a multicultural environment, offering a chance to contribute to critical regulatory processes and improve internal workflows.
Required Skills
Education
Vocational training in the technical or pharmaceutical field or equivalent experience (e.g., chemical, pharmaceutical, or biological technical assistant)
Experience
- Approximately 3 years professional working experience in Regulatory Affairs
- Experience including clinical trial initiation and maintenance
- Experience with regulatory procedures and requirements
Languages
Additional
- Not specified
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