JB-1702 Senior Executive - Regulatory Affairs
Core
Prepare, review, and maintain regulatory documents and submissions for pharmaceutical products, ensuring compliance with regulatory guidelines.
Role type
Senior Regulatory Affairs Executive
Builds
Regulatory dossiers, applications, renewals, variations, and amendments
Domain
Pharmaceutical industry + Regulatory Affairs
Required skills
Regulatory document preparation, dossier compilation, technical document review, QA document review, regulatory query response, regulatory tracker maintenance, audit/inspection support, regulatory guideline monitoring, data integrity management
Preferred skills
None stated
Technologies
None stated
Responsibilities
Prepare and review regulatory documents and submissions; Compile and coordinate regulatory dossiers and applications; Review technical documents and analytical data for compliance; Coordinate with QA, R&D, and Production; Review QA documents for regulatory requirements; Prepare responses to regulatory queries; Maintain regulatory trackers and documentation; Support regulatory audits and inspections; Monitor updates in regulatory guidelines
Seniority
Senior, hands-on IC
