Associate Specialist, Regulatory Affairs

About the role

MSD is hiring an Associate Specialist, Regulatory Affairs in Seoul (Seoul Square) on a one-year fixed-term contract. The role supports new marketing authorization applications, maintenance of product licences, regulatory compliance, document control, labelling and artwork review, working closely with local regulatory authorities and internal departments.

Key responsibilities

• Under supervision, prepare and submit new marketing authorization applications on time, coordinating with management, medical, finance, customer service, marketing and external affairs teams, and with local regulatory authorities
• Track product registration and major new indications
• Maintain marketing authorizations through variations, renewals and RMPs, and communicate approvals to stakeholders
• Build and maintain Regulatory Official Files and MA filing binders per local SOPs, and keep regulatory databases up to date
• Help set and follow SOPs and implement updated regulatory documentation per agency requirements
• Support other functions to enable regulatory compliance
• Assist in preparing, translating and quality-checking MA applications and post-approval submissions, including linguistic checks
• Develop packaging artwork (leaflets, labels, cartons) on time and proofread packaging components

Required profile

• Temporary (fixed-term) position of one year
• Valid driving licence
• Hybrid work arrangement

Required skills

• Adverse event reporting
• Compliance audits and regulatory compliance
• Data quality assurance and document control systems
• Electronic Common Technical Document (eCTD)
• Records retention management
• Regulatory strategy development