We are looking for a Regulatory Affairs Manager (m/f/d) in the pharmaceutical industry for a client for direct placement in Northeim.
Here's what our clients offer
1. Full-time employment
2. Personnel development opportunities
3. Attractive fixed salary
4. Comprehensive social package
5. Open corporate culture
6. Optimal induction/onboarding
7. Mobility benefits
8. Free gym & courses as well as numerous health campaigns
9. Latest and powerful Apple products with many new collaboration features for daily business
Your tasks
10. Managing the Regulatory Affairs department, including the preparation, review, processing and submission of documents to the relevant authorities
11. You develop and implement regulatory guidelines
12. Reviewing and complying with regulatory procedures and workflows
13. Development of optimal strategies
14. You will also interface with global regulatory authorities and external consultants
15. Training, mentoring and supervising employees, consultants & contractors in the area of regulation as well as developing the team are another part of your responsibilities
16. As a Regulatory Affairs Manager (m/f/d), you will continuously support interdisciplinary teams as an advisor on regulatory issues
Your profile
17. You have successfully completed your studies with a scientific focus
18. Experience in the field of medical devices or in the biotechnology industry
19. Proven experience in actively leading a team
20. Very good knowledge in the interpretation of regulations, guidelines, policy statements
21. You are experienced in the preparation of marketing authorization applications
22. Prioritization of work packages, both for yourself and for your team
23. You enjoy working effectively and cooperatively in cross-functional international teams
24. Fluent written and spoken German and English and a willingness to travel (max. 10%) round off your profile
25. You identify with our values of sustainability, openness & joy and are motivated to work in a dynamic company