Specialist Regulatory Affairs
Core
Manage regulatory submissions and lifecycle management for pharmaceutical products in Singapore and Brunei to ensure compliance with local legislations and company procedures.
Role type
Specialist Regulatory Affairs (Pharmaceuticals)
Builds
Product registrations, marketing authorization applications, and post-market regulatory dossiers for pharmaceutical products.
Domain
Pharmaceuticals / Healthcare
Required skills
Regulatory submission strategy, Marketing Authorization Applications, Lifecycle Management, regulatory compliance, audit support, procedural development, drug shortage management
Preferred skills
Knowledge of Singapore pharmaceutical regulations, project management, regulatory information management systems
Technologies
Microsoft Office, regulatory information management systems
Responsibilities
Develop product registration plans and strategies; prepare and submit new Marketing Authorization Applications; maintain authorized products through post-market submissions; archive and maintain regulatory data; ensure compliance with SOPs and manage CAPAs; support local audits and inspections; develop local procedures; identify procedural gaps and implement solutions; support drug shortage management.
Seniority
Mid-level Specialist (3-5 years experience)