Regulatory Affairs Oncology Manager

Job Description

Role Expectations

The Regulatory Affairs oncology manager is expected to ensure full regulatory compliance and timely product registration of Oncology products 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

•    Develop and implement regulatory strategies for oncology products in alignment with business objectives.
•    Monitor and interpret regulatory guidelines and policies, providing strategic advice to internal teams.
•    Prepare, review, and submit oncology and other drug registration dossiers in compliance with Vietnamese regulations  and monitor progress to ensure timeline  approval
•    Coordinate with cross-functional teams (Worldwide & regional RA, manufacturers and other departments).
•    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 packaging implementation. 

Educational & Professional Background :

•    Experience of Regulatory Affairs Manager position.
•    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  and especially, oncology registration. 
•    Ability to work with complex scientific documents (clinical data, CDx, pharmacokinetics).

Leadership Skills :

•    Demonstrated leadership and project management skills.
•    Strong problem-solving skills and ability to make decisions under pressure.

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 :

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

Candidate Profile