Regulatory Affairs Manager – Generics
Germany
Full Time
1 week ago
No Sponsorship
Key skills
CommunicationRemote Work
About this role
Role Overview
- Independently manage regulatory procedures for drug approval
- Prepare regulatory submission documentation in eCTD format and submit it to authorities
- Life-cycle management (renewals, variations)
- Maintain direct contact with regulatory authorities and act as a point of contact for internal and external Regulatory Affairs queries
- Maintain and optimize the regulatory information database
- Draft and review product information texts
Requirements
- A completed degree (e.g., pharmaceutical or natural sciences)
- Professional experience in Regulatory Affairs
- Excellent German and English language skills
- Analytical thinking, quick comprehension, and strong organizational skills
- Team player with strong communication skills
Benefits
- Flexible working conditions (including remote work)
- 30 days of vacation + 3 company bridge days
- A friendly team
- Attractive salary & comprehensive social benefits (including pension and health care)
- Excellent training and development opportunities