When our values align, there's no limit to what we can achieve.
We are seeking an experienced Regulatory Affairs Consultant specializing in global labelling operations to join our growing Regulatory Affairs team. This role offers the opportunity to shape labelling strategy across multiple markets and drive global alignment of product information for pharmaceutical portfolio of our clients.
The role can be fully home based or office based.
Key Responsibilities:
1. Manage end-to-end labeling lifecycle including preliminary assessment, implementation, and post-approval maintenance
2. Provide innovation and technical expertise for the creation, maintenance, and implementation of labeling to meet country-specific regulatory requirements
3. Execute labeling operations globally with precision and efficiency
4. Participate in a 'follow the sun' model to ensure timely execution of labelling activities across time zones
5. Prepare and review labelling documents for regulatory submissions and variations
6. Maintain labeling databases and tracking systems
7. Support global labelling harmonization initiatives
8. Collaborate with regional regulatory teams to ensure compliance with local requirements
9. Monitor regulatory intelligence related to labelling requirements
Skills and Experienced required for the role:
10. University degree in a life science discipline
11. A few years of experience in the biotech/pharmaceutical industry
12. Labelling/regulatory experience with global responsibilities
13. Experience with CCDS development and maintenance
14. Strong understanding of regulatory labelling requirements across multiple markets
15. Direct experience working with BfArM
16. Excellent attention to detail and organizational skills
17. Experience leading teams in a matrix organization is expected
18. Ability to work effectively in a global, virtual team environment
19. Fluent in German and English, written and spoken