Tuyển dụng Regulatory Affairs Manager tại Hồ Chí Minh

Product Registration & Portfolio Lifecycle Management:

• Lead end-to-end registration, post-approval variations, license renewals, and withdrawals for a diverse portfolio including General Foods, Health Supplements, OTC Drugs, Generics, and Medical Devices.
• Ensure full compliance of all regulatory dossiers with updated national frameworks and local guidelines.

Authority Engagement & Liaison:

• Act as the primary point of contact with key government agencies, including VFA, DAV, FSA, NPRA, MDA, and related health authorities.
• Proactively track submission statuses, address official queries/deficiencies, and expedite application approvals.

Strategic Planning & External Collaboration:

• Partner with internal stakeholders, Managing Director, and RA Lead to formulate regulatory strategies for new product introductions and regional expansion.
• Coordinate effectively with external stakeholders (consultants, CMOs/manufacturers, testing labs, and distributors) to keep regulatory milestones on track.

Operational & Management Support:

• Participate in regulatory meetings, briefings, and audits; provide actionable insights for executive decision-making.
• Execute additional tasks and ad-hoc projects assigned by Executive Leadership and RA Management.

Yêu cầu công việc

Education: Bachelor’s Degree in Pharmacy, Pharmaceutical Sciences, Food Science, Life Sciences, or a related field.

Experience: 5–6 years of hands-on Regulatory Affairs experience spanning food/supplements, pharmaceuticals, or medical devices.

Regulatory Expertise:

• Proven expertise in Vietnamese regulatory frameworks.
• Hands-on familiarity with submission portals and procedures under DAV, VFA, NPRA, and MDA.

Key Skills:

• Proficiency in written and spoken English and Vietnamese.
• Strong project management skills with the ability to handle multiple priorities and strict deadlines independently.
• High analytical accuracy, sharp communication, and strong strategic thinking skills.

Quyền lợi

• Khác: 13-month salary, Performance Bonus, Annual Leave, etc.