Regulatory Affairs Manager

Navigos Search · Hồ Chí Minh

Loại hình

Toàn thời gian

Hình thức

Tại văn phòng

Cấp bậc

Trưởng / Phó phòng

Ngành nghề

Ngành nghề khác

Mức lương

Thương lượng

Địa điểm

Hồ Chí Minh, Hồ Chí Minh, Hồ Chí Minh

Tổng quan

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.

Regulatory Affair, Pharmaceutics, Pharmaceutical Healthcare, Nutrition, CosmeticQuyền lợi:
13-month salary, Performance Bonus, Annual Leave, etc.

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