Associate Regulatory Affairs - External Manufacturing (Fixed Term Contract)
Core
Authoring, compiling, and publishing regulatory submissions for externally manufactured generic drugs and supporting lifecycle management for North America business.
Role type
Associate Regulatory Affairs (External Manufacturing)
Builds
Regulatory submissions (CMC, NDA, ANDA), Annual Reports, GDUFA filings for externally manufactured products
Domain
Pharmaceuticals (Generic Drugs), Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC submissions, 21 CFR regulations, ICH guidelines, pharmacopeia knowledge, dosage form requirements, regulatory compliance systems
Preferred skills
RAC certification, generic pharmaceutical industry experience
Technologies
GDUFA systems, regulatory filing platforms
Responsibilities
Authoring and compiling regulatory submissions (CMC supplements, NDAs, ANDAs); Coordinating with CMOs for document collection and change controls; Managing post-approval changes (PAS/CBE-30/CBE-0) and Annual Reports; Maintaining FDA communication files; Supporting cross-functional teams for external products; Managing GDUFA submissions (fees, registrations, volume reporting)
Seniority
Mid-level, hands-on IC