Regulatory Affairs Personnel

4 days ago


Singapore HAATON CAPITAL PTE. LTD. Full time

The Regulatory Affairs (RA) Personnel contributes to the regulatory function by registering, attaining and maintaining marketing authorisation of therapeutic products.

Key Responsibilities
- Prepare and review registration dossiers for submission to drug regulatory agency
- Coordinate with overseas suppliers and partners to ensure accurate and complete submission of registration dossiers
- Respond to queries from drug regulatory agency on a timely manner
- Review marketing materials to ensure compliance to regulatory guidelines
- Stay up to date on regulations to ensure continued compliance of registered therapeutic products

**Qualifications**:
1. Degree or advanced diploma in life science / chemistry / pharmaceutical science, with min. 3 years of relevant working experience

2. Knowledge of regulatory guidelines, including ICH and ASEAN

3. Good understanding of GMP and GDP



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