Regulatory Affairs Specialist

2. Applies knowledge in regulations and characteristics of products to prepare compliant regulatory strategies and to assess regulatory impact on products as product life-cycle management.

3. Interacts with regulatory agency personnel in order to expedite approval applications and to resolve regulatory matters with a certain degree of supervision.

4. Communicates information and presents status updates on product/project activities to key internal/external stakeholders when requested.

5. Follows up of mandatory requirements for registration: local certificates, importation of samples, local testing, etc. with a certain degree of supervision.

6. Ensures Korean label contents and approves the final Korean label artwork.

7. Researches and consolidates regulatory requirements and actively communicates with the supervisor and the manager.

8. Supports projects in the RA team and the enhancement for Regulatory Affairs processes.    Conforms regulatory compliance.

9. Understands business environment and business strategies and develops effective and results-oriented regulatory strategic plans that are in line with business objectives. Manages specific project steps to meet milestones independently, with some supervision or as a part of the team.

10. Understands the major trends in the healthcare environment, changes in external marketplace, and competitors’ tendency and the influence of social, economic, and political factors on business and regulatory environment.

- Min. 2 years of experience in Regulatory Affairs

- Understanding in regulatory requirements, laws, standards, and environment

- The incumbent must have the ability to work effectively with limited supervision and process requests/work within required timeframes

- Strong communication and interpersonal skills

- Fluent in both verbal and written English