Regulatory Affairs Officer/Specialist

Role Expectations

The Regulatory Affairs Officer/Specialist is expected to ensure full regulatory compliance and timely product registration in alignment with local and global strategies. They need to proactively monitor regulatory changes, propose proper solutions, maintain effective communication with authorities and strong cross-functional collaboration to support business.

Main Responsibilities

- Prepare, review, and submit oncology and other drug registration dossiers in compliance with Vietnamese regulations.

- Monitor dossier progress, respond to inquiries, and prepare justifications for authority requests to ensure timely and accurate submissions of new drug applications, amendments, supplements.

- Coordinate with cross-functional teams (Worldwide & regional RA, manufacturers and other departments).

- Keep updated with the latest pharmaceutical regulations in Vietnam and guidelines.

- Ensure compliance with national and industry-specific regulations. Interpret new rules and implement them throughout the company by updating policies and procedures.

- Handle post-approval activities such as renewal, variation, and dossier updates.

Educational & Professional Background

- Bachelor’s degree in Pharmacy

- Solid knowledge of Vietnamese pharmaceutical regulations (Law on Pharmacy, Decree, Circulars)

- Proficiency in preparing and reviewing CTD dossiers (Common Technical Document).

- Familiarity with working with the Drug Administration of Vietnam (DAV), Ministry of Health, and relevant authorities

- Sufficient knowledge of oncology drugs to ensure the quality of regulatory submissions.

Hard Skills

- Experience in dossier preparation for originators

- Strong ability to read and interpret scientific and regulatory documents in English.

- Minimum 5 years of experience in regulatory affairs or drug registration and especially, oncology.

Soft Skills

- Attention to detail, accuracy, and good time management.

- Effective communication skills to liaise with regulatory bodies and international partners.

- Proficiency in regulatory submission internal data system, software and tools.

Other

- Ability to work with complex scientific documents (clinical data, CDx, pharmacokinetics).

- Capable of working independently as well as in a team environment.