Job Description
:
Director, Regulatory Affairs
Would you like to join and contribute to a successful and growing multi-national organization in the heart of Europe and one of the world’s leading regions of the pharmaceutical industry? Veristat is hiring a Director Regulatory Affairs, responsible for strategic and operational regulatory consulting for client companies. The Director RA at Veristat will be client facing and will be responsible amongst others for:
1. Leading regulatory clinical trial services ex North America, with focus on Europe.
2. Leading regulatory activities on assigned projects, working independently and within cross functional consulting and clinical teams
3. Develop and lead regulatory strategy and operational implementation during product development, registration and post-approval, ensuring regulatory compliance of assigned projects
4. Independent preparation of regulatory documentation such as PIPs, ODDs, Scientific Advice requests and lead interactions with Health Authorities
5. Interactions with client contacts
6. Coaching junior team members
What we do
For 30 years, Veristat has built a reputation as global experts in clinical development.
7. 760+ Rare Disease Clinical Trials supported
8. 160+ Marketing Applications supported
9. In 2022 we supported 8 marketing application that received regulatory approval
10. Learn more about our core values here!
What we offer
11. A stimulating role in an international and dynamic work environment
12. Continuous development and training opportunities
13. Office or Home-Based working
14. Rewards for outstanding accomplishments
What we look for
15. An experienced Regulatory Affairs professional with 10+ years’ experience in Regulatory Affairs in the pharmaceutical industry or CRO/consultancy
16. Scientific Degree with preference for MSc or PhD
17. Experience with line management
18. Experience with set-up of clinical RA systems and processes, clinical trial conduct, CTIS, leading collaboration with Clinical Operations, Start up, PM, essential. Europe essential, other markets and ATMPs and GMO experience a plus.
19. Experience with leading regulatory activities during early development, marketing authorization and post-approval phase, including agency interactions, PIPs, ODDs, Scientific Advice meetings, MAAs etc. Europe essential, other markets a plus.
20. Global regulatory experience is a plus
21. Excellent communication skills
Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process.
Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.