외국계제약사 Regulatory Affairs Associate

RESPONSIBILITIES:

1. Regulatory responsibilities
- Support custom clearance for products (cosmetics, drugs, etc.)
- Work for regulatory approval or license maintenance of license-in products
- Review and approval of marketing materials, label, packaging and artwork, in accordance with local regulatory requirements

2. Quality responsibilities
- Quality control management for drug, MD (QC release, QC documentations)
- Implement and maintain quality documentations of drug, MD regarding quality local testing, import, etc.
- Ensure compliance with Korea GMP and GSP guidelines and regulations of the contracted warehousing, laboratory testing and distribution activities

QUALIFICATIONS:

- Bachelors degree or above
- Pharmacist preferred
- 3-10 years’ experience in pharma industry (more experience can be discussed.)
- Fluent in English (written and verbal communication)