Regulatory Affairs Manager – Animal Health
msd · VNM - Ho Chi Minh - Ho Chi Minh City (Le Duan)
Job description
About the role
The Regulatory Affairs Manager – Animal Health will lead the registration, lifecycle management and compliance of veterinary products in Vietnam, ensuring alignment with local regulations and global standards.
Key responsibilities
- Compile, review, translate and submit registration dossiers for new animal‑health products in Vietnam.
- Maintain and update existing marketing authorizations, handling variations, extensions and renewals.
- Serve as primary liaison with Vietnam’s competent animal‑health authorities, managing submissions, queries and compliance issues.
- Oversee product‑label conformity, import/export permits and ensure regulatory operational compliance.
- Monitor local veterinary legislation, provide regulatory intelligence and review promotional and technical materials for compliance.
- Maintain inspection‑ready regulatory records throughout the product lifecycle.
- Act as the Vietnam pharmacovigilance contact, handling adverse event reporting, safety complaints and local PV procedures.
Required profile
- Bachelor’s degree or higher in Veterinary Medicine, Pharmacology, Animal Science, Biology or related field.
- Minimum six years of regulatory affairs experience in pharmaceutical, veterinary or biotech sectors, preferably animal‑health.
- Proven experience interacting with Vietnam’s animal‑health authorities and managing registration, labeling, import/export, advertising and pharmacovigilance requirements.
- Demonstrated ability to work in a matrixed multinational environment and collaborate with regional/global regulatory teams.
- Self‑driven, detail‑oriented and able to meet tight timelines with minimal supervision.
Required skills
- Regulatory Affairs Management
- Regulatory Compliance
- Regulatory Documents
- Regulatory Inspections
- Regulatory Processes
- Regulatory Strategy Development
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Published 1 tuần trước
Expires 1 tháng tới
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msd
VNM - Ho Chi Minh - Ho Chi Minh City (Le Duan)
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