RA (Senior) Specialist/Associate Manager
Core
Develop regulatory strategy and manage product registration procedures for new pharmaceutical products to ensure earliest market entry in Korea.
Role type
Senior Regulatory Affairs Specialist / Associate Manager
Builds
Regulatory compliance and market entry for pharmaceutical products in Korea
Domain
Pharmaceuticals / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory strategy planning, product registration management, label harmonization, safety information updates, lifecycle maintenance, package compliance, regulatory intelligence gathering, cross-functional collaboration, drug development process knowledge
Preferred skills
Knowledge of Good Regulatory Practice (GRP), experience with Korean MFDS regulations
Technologies
None stated
Responsibilities
Develop regulatory strategy for new product launches in Korea, manage product registration procedures, harmonize product labels with local regulations, update safety information, maintain product license compliance, ensure package compliance, review promotional literature for regulatory compliance, gather regulatory intelligence, maintain relationships with government agencies and authorities
Seniority
Senior, hands-on IC
