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
