Regulatory Affairs Officer-Registration
Core
Prepare EU/UK registration dossiers (Module 1) and manage lifecycle submissions for generic pharmaceutical products.
Role type
Regulatory Affairs Officer (Registration)
Builds
Regulatory dossiers for generic drug registration
Domain
Pharmaceuticals / Regulatory Affairs
Required skills
Module 1 dossier preparation, eCTD management, authority query response, EU/UK regulatory compliance
Preferred skills
M.Sc. in Pharmacy
Technologies
eCTD, MS Office
Responsibilities
Compile Module 1 of registration dossiers (PIL, SmPC, ERA, RMP), prepare dossier sequences (initial MAA, variation, renewal) in eCTD, manage authority queries and deficiency responses, maintain eCTD sequence and lifecycle
Seniority
Mid-level (3-4 years experience)