BridgeBio-- Regulatory Affairs Postdoctoral Research Fellow
Core
Two-year Regulatory Affairs fellowship supporting Eidos (BridgeBio affiliate) development programs, including regulatory strategy, global labeling, and advertising/promotion review.
Role type
Regulatory Affairs Postdoctoral Research Fellow
Builds
Regulatory submissions (IND, NDA, CTA), global labeling documents, and promotional material reviews for FDA and health authorities.
Domain
Biopharmaceuticals / Genetic Medicine
Required skills
Regulatory strategy development, Veeva regulatory management system proficiency, knowledge of ICH/GCP/GMP guidelines, cross-functional collaboration, labeling regulation expertise, MLR review coordination
Preferred skills
None stated
Technologies
Veeva
Responsibilities
Manage and implement regulatory strategy for development programs; support preparation of regulatory submissions (IND, NDA, CTA); maintain core labeling documents and support labeling strategy; support regulatory review of promotional and non-promotional materials.
Seniority
Postdoctoral Fellow, early-career industry training