Regulatory Affairs Manager (all Genders)

165

Frankfurt am Main, Germany
Hybrid
3+ years regulatory affairs experience in germany
German and english fluency required
Natural sciences degree (pharmacy/chemistry/biology)
The role involves leading regulatory strategies for OTC medicines, medical devices, and prescription-to-OTC switches from concept to launch

Job Summary

  • The role involves leading regulatory strategies for OTC medicines, medical devices, and prescription-to-OTC switches from concept to launch.
  • Candidates will ensure product safety and quality by managing the full life cycle and acting as the official information officer under German law.
  • Opella offers a collaborative culture focused on making self-care simple for over 500 million consumers worldwide.

Matching Summary

The role involves leading regulatory strategies for OTC medicines, medical devices, and prescription-to-OTC switches from concept to launch.

Skills & Requirements

Must-have

  • 3+ years Regulatory Affairs experience in Germany
  • German and English fluency required
  • Natural sciences degree (Pharmacy/Chemistry/Biology)
  • OTC drug regulatory strategy development
  • AMG §74 Information Officer responsibilities

Nice-to-have

  • Experience with medical devices and supplements
  • MDRA certification preferred
  • Strong communication and team collaboration skills
  • Business-oriented strategic thinking
  • Flexible and self-structured work style

Key Requirements

  • Minimum 3 years Regulatory Affairs experience
  • Degree in Natural Sciences (Pharmacy, Chemistry, Biology)
  • Fluent in German and English
  • Knowledge of German Medicines Act (AMG)

Work Rights

Not specified

Tailored Resume

Cover Letter