Jr. Regulatory Affairs Specialist

About the role

The Junior Regulatory Affairs Specialist will manage lifecycle activities for mature products and support the development and registration of new products, ensuring compliance with Korean regulatory requirements, Servier Group standards, SOPs and OPMs. The role reports to the Head of Regulatory Affairs & Quality.

Key responsibilities

• Provide regulatory input to develop strategies and liaise with the MFDS in collaboration with Worldwide Regulatory Affairs.
• Manage lifecycle and maintenance activities for registered products, including preparation and submission of Marketing Authorization and Drug Master File applications.
• Support patent listing on the Green List where applicable.
• Prepare and submit clinical trial applications for products under development.
• Handle regulatory compliance tasks such as variation dossiers, product renewals, and validation of packaging, labels and inserts.
• Conduct change‑control evaluations and maintain regulatory information systems (e.g., Veeva).
• Serve as primary contact for MFDS inspections (GMP, GCP) within assigned scope.
• Monitor Korean pharmaceutical legislation and advise internal teams on regulatory changes.
• Maintain regulatory affairs documentation, including SOPs and OPMs.
• Execute other duties and special projects as assigned by the Head of Regulatory Affairs & Quality.

Required profile

• Minimum of one year experience in Regulatory Affairs (mandatory).
• Pharmacist qualification preferred.
• Functional knowledge of pharmaceutical regulations.
• Strong cross‑functional and interpersonal communication skills.
• Fluent in written and spoken English.
• Leadership behaviours: commitment, self‑discipline, collaboration and a compliance‑focused mindset.