Main Responsibilities:
1. Define and execute EU regulatory strategies in alignment with global development plans
2. Serve as primary EU regulatory contact with EMA and coordinate interactions with National Competent Authorities
3. Lead preparation and execution of Scientific Advice, regulatory meetings, and related briefing packages
4. Oversee EU regulatory submissions including IMPDs, PIPs, Orphan Drug Applications, MAAs, variations, and life-cycle updates
5. Ensure EU labeling compliance and alignment with the Company Core Data Sheet
6. Represent Regulatory Affairs on cross-functional project and governance teams
7. Maintain regulatory intelligence and assess impact of new guidance and regulations
8. Contribute regulatory expertise to due diligence and business development activities
9. Develop and lead global regulatory strategies and Regulatory Functional Plans
10. Coordinate global submission planning and execution
11. Own creation and maintenance of the global Company Core Data Sheet
12. Lead regulatory sub-teams and ensure delivery of regulatory milestones
13. Support affiliates and partners with global regulatory strategy and execution
Qualifications and Experience:
14. Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required;
15. Master’s degree (or equivalent) in Life Sciences or related discipline
16. 8+ years of Regulatory Affairs experience within pharma or biotech
17. Expert knowledge of EU, ICH, and global regulatory frameworks
18. Extensive experience working with EMA and EU National Competent Authorities
19. Strong understanding of clinical development and regulatory life-cycle activities
20. Excellent communication, stakeholder management, and project leadership skills
21. Fluent English (written and spoken)