Job Description

Mission

The primary focus of the Junior Regulatory Affairs Specialist role is to manage lifecycle activities for mature products and contribute to the development and registration of new products, in compliance with Korean regulatory requirements, Servier Group standards, SOPs, and OPMs.

This position reports to Head of Regulatory Affairs & Quality.

Job Description

Candidate Profile

Activities & Responsibilities

The Junior Regulatory Affairs Specialist is responsible for assigned regulatory affairs activities across product development, registration, and lifecycle management, under the supervision of the Head of Regulatory Affairs and Quality:

• In collaboration with Worldwide Regulatory Affairs (WRA), the Junior Regulatory Affairs Specialist provides regulatory input to support the development of regulatory strategies, consultations with the MFDS, and related activities.
• The Junior Regulatory Affairs Specialist is primarily responsible for lifecycle management and maintenance activities for registered products. As assigned, the role prepares and submits Marketing Authorization (MA) and Drug Master File (DMF) applications under the guidance of the Senior Regulatory Affairs Specialist and the Head of Regulatory Affairs and Quality. The role also provides regulatory support related to patent listing in the Green List, if applicable.
• For products under development, in collaboration with WRA, the Junior Regulatory Affairs Specialist is responsible for the preparation and submission of clinical trial applications.

For marketed products, the Junior Regulatory Affairs Specialist, in collaboration with WRA, is responsible for:

• Activities related to regulatory compliance;
• Submission of variation dossiers;
• Submission of dossiers for product renewals;
• Validation of packaging materials, labels, package inserts, etc.;
• Change control evaluations; and
• Creation and maintenance of regulatory information systems (e.g., Veeva).

The Junior Regulatory Affairs Specialist is the primary point of contact for all interactions with the MFDS, including inspections (GMP, GCP), within the scope of his/her responsibilities as assigned by the Head of Regulatory Affairs and Quality.

The Junior Regulatory Affairs Specialist is responsible for maintaining awareness of current legislation in Korea and advising WRA and the Clinical Operations Department in Korea on changes in pharmaceutical legislation and regulatory authority requirements.

The Junior Regulatory Affairs Specialist is responsible for maintaining regulatory affairs documents, including SOPs and OPMs.

The Junior Regulatory Affairs Specialist is responsible for performing other related duties and special projects as assigned by the Head of Regulatory Affairs and Quality.

Requirements

• A minimum of one year of experience in Regulatory Affairs is mandatory. Pharmacist is preferred.
• Functional knowledge: Pharmaceutical regulations.
• Cross-functional and interpersonal communication skills.
• Fluent in both written and spoken English.
• Leadership behaviors: Commitment, self-discipline, collaboration, and a compliance-focused mindset.