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Regulatory Affairs Associate Director
3 weeks ago
We are looking for a highly skilled and experienced professional to join our team as an Associate Director, ExploR&D Regulatory Affairs. The successful candidate will have a strong background in regulatory affairs and drug development experience, with a focus on early phase clinical development.
The Associate Director will provide strategic, tactical, and operational direction and support to deliver global regulatory strategies from candidate selection to clinical proof of concept for assigned assets. They will manage all regulatory activities (strategy and implementation) for assigned programs across different therapeutic areas and geographies, with focus on US, Canada, UK, EU, and Australia.
The ideal candidate will have excellent communication and interpersonal skills, with the ability to connect and influence at various levels across disciplines, both externally and internally.
Responsibilities:- Collaborate to develop and initiate effective regulatory strategies, focused on preparing CTA/INDs to support Phase 1 and 2 clinical development of externally owned assets.
- Exercise Accountability for Knowledge Transfer across ExploR&D and GRA
