
Regulatory Affairs Manager
1w1 week agoSanofi
Frankfurt am Main, DE · Full-time · €70,000 – €100,000
About this role
Opella is an international, future-oriented company redefining the market for over-the-counter medicines with innovative concepts. Our mission is to make selfcare as simple as possible, empowering over 500 million consumers worldwide. As Regulatory Manager Germany at our Frankfurt site, you handle regulatory responsibility for development projects and OTC-switches from product idea to launch.
You ensure product safety and quality through life-cycle management, advertising, and product information as the designated Information Officer under § 74 AMG. Daily tasks include developing strategies for OTC medicines, medical devices, and switches from prescription drugs in interdisciplinary teams. You evaluate external registration documents and manage approvals via national, MRP, and DCP procedures.
Work closely with global and local functions, communicating with authorities on deficiency letters and scientific advice meetings. Join A. Nattermann & Cie. GmbH, producer of leading brands like Allegra, Buscopan, DulcoLax, Thomapyrin, and Mucosolvan. Our global headquarters is in Paris, with 13 production sites including one in Cologne and over 11,000 employees.
As the world's first B Corp-certified Fast-Moving-Consumer-Health company, we actively commit to a healthier future and environment. Contribute to our German CHC portfolio in a business-oriented, structured environment. Learn more at www.opella.com.
Requirements
- At least 3 years professional experience in Regulatory Affairs for medicines in Germany and EU
- Additional experience in medical devices and food supplements advantageous
- Experience in medical devices and food supplements advantageous
- Commitment, flexibility, strong communication and team skills
- Efficient, independent, structured, and careful working style
- Business-oriented thinking
- Strong PC skills and willingness to work with complex regulatory databases
Responsibilities
- Develop regulatory strategies for OTC medicines, medical devices, and OTC-switches of prescription drugs in close coordination with global and local functions in interdisciplinary teams
- Evaluate external registration documents (Due Diligence)
- Develop regulatory defense strategies in case of product risks
- Plan, organize, and execute activities for application and maintenance of drug approvals (national, MRP, DCP)
- Communicate with authorities on deficiency letters, official requirements, and conduct Scientific Advice Meetings
- Create, review, and approve product information texts
- Approve advertising materials including responsibility as Information Officer for defined medicines
Benefits
- Part of global team with over 11,000 engaged employees
- Work at 13 production sites including Cologne
- Four specialized centers for research and innovation
- World's first B Corp-certified Fast-Moving-Consumer-Health company
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