[Duties]
The primary focus of the (Jr.) 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 in compliant with Korean regulatory requirements and Group standards/SOPs/OPMs.
[Responsibilities] 1 Year Contract
The (Jr.) Regulatory Affairs Specialistis in charge of all phases of development projects across a wide range of products as assigned by Head of Regulatory Affairs:
- In collaboration with Worldwide Regulatory Affairs (WRA) in Paris, the (Jr.) 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 (Jr.) Regulatory Affairs Specialistis responsible for the submission and management of DMF dossiers and MA submission dossiers including clinical data package and the regulatory support required in relation to patent listing to the Green list, if applicable.
- Regarding products under development in collaboration with WRA in Paris, the (Jr.) Regulatory Affairs Specialistis responsible for the preparation and the submission of clinical trial applications.
Regarding marketed products, the (Jr.) Regulatory Affairs Specialistin collaboration with WRA is responsible for:
- Activities related to Quality compliance,
- Validation of packages, labels, package-insert, etc.,
- Submission of the dossiers for product renewals,
- Submission of variation dossiers,
- Change control evaluations.
The (Jr.) Regulatory Affairs Specialistis the primary responsible person for all interactions with MFDS including inspections (GMP, GCP) under the scope of his/her responsibility as assigned by Head of Regulatory Affairs.
The (Jr.) Regulatory Affairs Specialistis 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 (Jr.) Regulatory Affairs Specialistis responsible for regulatory affairs documents including SOPs and OPMs.
The (Jr.) Regulatory Affairs Specialistis responsible for performing other related duties and special projects as assigned by Head of Regulatory Affairs.
[Qualification]
- 2+ years of experience in Regulatory Affairs. Pharmacist is preferred.
- Functional Knowledge: Pharmaceutical Regulations.
- Skills: Cross-functional and interpersonal communication, Fluent in both written and spoken English.
- Leadership Behaviors: Commitment/Self-discipline, Quality/compliance focus
The Regulatory Affairs Jr. Specialist reports to the Head of Regulatory Affairs, Servier Korea.