Sr. Regulatory Affairs Specialist
Duties
The primary focus of the Senior Regulatory Affairs Specialist is to deal directly with the Ministry of Food and Drug Safety (MFDS) for the development and registration of new chemical entities and also for the life cycle management of mature products.
RESPONSIBILITIES
The Senior Regulatory Affairs Specialist is in charge of all phases of development projects across a wide range of products:
- In collaboration with Worldwide Regulatory Affairs (WRA) in Paris, the Senior Regulatory Affairs Specialist, is giving guidance on regulatory issues in order to prepare the regulatory strategy, the consultations with MFDS and all related activities.
- Regarding products under development in collaboration with WRA in Paris, the Senior Regulatory Affairs Specialist is responsible for the submission and management of DMF dossiers and NDA dossiers including clinical data package and the submission of patent- linkage data for listing on the Green-list
- Regarding products under development in collaboration with WRA in Paris, the Senior Regulatory Affairs Specialist is responsible for the preparation and the submission of clinical trial applications
- In setting-up country submission strategy and plan, and in the project management of NDAs, major variations and regulatory issues, Senior Regulatory Affairs Specialist works independently, as aligned in the direction of Head of Regulatory Affairs.
- Under the guidance of Head of Regulatory Affairs, Senior Regulatory Affairs Specialist provides advice and support to (Jr.) Regulatory Affairs Specialist regarding the regulatory expertise, submission management and consultation with MFDS etc.
Regarding marketed products, the Senior Regulatory Affairs Specialist in collaboration with WRA is responsible for:
- Activities related to Quality compliance (local QC results review, batch release approval as an import supervisor (if applicable), analytical method transfer to contracted laboratory, batch recall management, etc.)
- validation of packages, labels, package-insert, etc,
- submission of the dossiers for product renewals or re-examinations,
- submission of variations of dossiers,
- submission of variations of patent-linkage data for listing on the Green-list
- interacting with licensees.
The Senior Regulatory Affairs Specialist is the primary responsible person for all interactions with MFDS including inspections (GMP, GCP).
The Senior Regulatory Affairs Specialist is responsible for maintaining a constant awareness of the current legislation in Korea and for advising WRA and Clinical Operations Department Korea (for clinical trial application) on changes regarding pharmaceutical legislation and regulatory authorities.
The Senior Regulatory Affairs Specialist is responsible for regulatory affairs documents including SOPs and OPMs:
- writing and reviewing the local SOPs and OPMs to check their compliance with Korean regulations and Group SOPs,
- reviewing the SOPs and the pharmacovigilance related documents to be submitted to MFDS, the activities related to pharmacovigilance in collaboration with PV Manager,
- ensuring that all the records are archived securely in accordance with Korean and company requirements,
The Senior Regulatory Affairs Specialist is responsible for performing other related duties and special projects as assigned by Head of Regulatory Affairs, General Manager and/or Head Office.
Qualification
- 5+ years of experience in Regulatory Affairs. Pharmacist is preferred.
- Good knowledge in Pharmaceutical Regulations and expertise in regulatory submission and interaction with MFDS for prescription drugs
- Skills: Cross-functional and interpersonal communication, Fluent in both written and spoken English.
- Leadership Behaviors: Commitment/Self-discipline, Quality/compliance focus
The Sr. Regulatory Affairs Specialist reports to the Head of Regulatory Affairs, Servier Korea.