About the job
Core
Establishing drug approval strategies and managing regulatory affairs for pharmaceuticals, including post-approval management and monitoring regulatory changes.
Role type
Regulatory Affairs Specialist (Pharmaceuticals)
Builds
Regulatory submissions and compliance for pharmaceutical products
Domain
Pharmaceuticals / Healthcare
Deliverable
client delivery
Required skills
Drug approval process knowledge, regulatory compliance, stakeholder management with regulatory bodies, monitoring regulatory changes
Preferred skills
Experience with DMF changes, overseas manufacturing facility registration
Technologies
Regulatory databases, submission platforms
Responsibilities
Formulating drug approval strategies, managing post-approval regulatory tasks, monitoring domestic and international regulatory changes, reviewing regulations and liaising with the Ministry of Food and Drug Safety
