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Regulatory Affairs Manager – Animal Health

msd · VNM - Ho Chi Minh - Ho Chi Minh City (Le Duan)

Senior 🇬🇧 English
Regulatory Affairs Management Regulatory Compliance Regulatory Documents Regulatory Inspections Regulatory Processes Regulatory Strategy Development

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

Questions fréquentes

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Source : ats:workday

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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)