Executive, Regulatory Affairs NPD US & Can
Core
Prepare regulatory submissions and deficiency responses for Injectables (Sterile Dosage Forms) to US and Canadian agencies.
Role type
Senior Regulatory Affairs Executive (NPD)
Builds
Regulatory dossiers for sterile injectable products
Domain
Pharmaceuticals (Generics/Biosimilars) and Regulatory Compliance
Required skills
Regulatory submission preparation, Deficiency response management, Change control assessment, Database maintenance, Cross-functional coordination, SOP drafting
Preferred skills
Project Management, Third-party manufacturer coordination
Technologies
MS-Office suite (Word, Excel, Project)
Responsibilities
Prepare and review quality regulatory NPD submissions for US and Canada; Maintain regulatory documents and databases; Coordinate deficiency responses; Assess change control documents; Draft SOPs and regulatory guidelines.
Seniority
Senior, hands-on IC