19 days ago
Associate Director, Regulatory Affairs
Do you want to be part of a biopharmaceutical company that is passionate about developing best-in-class therapeutics that address significant unmet medical needs?
My client is looking to hire an experienced Associate Director, Regulatory Affairs to join their team. This is an exciting opportunity to join a rapidly growing, innovative company!
- Maintains knowledge of complex regulatory requirements in order to properly develop global regulatory strategies (clinical, non-clinical and CMC)
- Provides guidance in translating regulatory requirements into practical plans for project teams with international participants.
- Contributes to the development of global clinical and regulatory plans and strategies, identifies and proposes risk mitigation strategies, and influences project teams and sub teams across international site locations.
- Contributes to development of global labeling documents
- In charge of mentoring and supervising other regulatory professionals
- 7-9 years regulatory experience required
- 2-4 years managing experience preferred
- Must be able to effectively lead teams in preparation of submissions