Regulatory Affairs Manager- Animal Health

MSD • mPlaza Saigon,No. 39 Le Duan Street,Sai Gon Ward,Ho Chi Minh City,Hồ Chí Minh 700000,Vietnam

Trách nhiệm chính

Manage new product approvals by compiling, reviewing, translating, and submitting high-quality dossiers for biological and pharmaceutical products.
Oversee registration lifecycle including variations, extensions, and renewals to ensure compliance.
Act as the primary contact for Vietnam animal health authorities and relevant government bodies.
Manage product-standard conformity declarations and coordinate import/export permits.
Monitor and interpret local veterinary laws and communicate regulatory developments to stakeholders.
Review promotional, digital, and technical materials for alignment with veterinary advertising requirements.
Maintain inspection-ready regulatory records and documentation.
Serve as the Country Pharmacovigilance contact, ensuring compliance and timely reporting of adverse events and complaints.
Coordinate PV procedures, conduct training, and ensure appropriate safety clauses in agreements.
Collaborate with global and regional teams to align strategies and share best practices.

Yêu cầu công việc

Bachelor’s degree or higher in Veterinary Medicine, Pharmacology, Animal Science, Biology, or a related field.
Minimum 6 years of experience in Regulatory Affairs within pharmaceutical, veterinary, or biotechnology sectors.
Demonstrated experience engaging with Vietnam animal health authorities.
Proficiency in local veterinary registration, labeling, import/export, advertising, and pharmacovigilance requirements.
Proven effectiveness in a matrixed multinational environment.
Native Vietnamese and professional-level English proficiency.
Strong analytical, logical problem-solving, and negotiation skills.

Yêu cầu ưu tiên

Mức lương

Hình thức làm việc

Thông tin khác

Employment Status: Regular.
Hạn nộp hồ sơ: 2026-10-25 (Hạn cuối là ngày trước ngày kết thúc đăng tuyển 26/10/2026).

Regulatory Affairs Manager- Animal Health