Alnylam Pharmaceuticals – Regulatory Affairs Postdoctoral Research Fellow
Core
Two-year Regulatory Affairs fellowship supporting expedited drug development and approval of Alnylam's RNAi therapeutics for rare and common diseases.
Role type
Regulatory Affairs Postdoctoral Research Fellow
Builds
Investigational new drug applications, clinical trial applications, new drug applications, and international marketing authorization applications
Domain
Biopharmaceuticals / RNAi therapeutics / Global Regulatory Strategy
Required skills
Global regulatory strategy, regulatory filing preparation, cross-functional collaboration, guidance research, project management
Preferred skills
None stated
Technologies
None stated
Responsibilities
Support, prepare, and submit regulatory filings including INDs, CTAs, NDAs, and international marketing authorization applications; Participate in cross-functional meetings to support clinical development plans and regulatory strategy; Conduct guidance and precedent research; Support lifecycle maintenance submissions for commercial programs
Seniority
Postdoctoral Fellow, early-career industry training