Regulatory Affairs Oncology Manager

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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 de...