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Merck

Makes medicines, vaccines and animal treatments

Regulatory Affairs Manager - Animal Health

Full-TimeUpdated on 10/23/2026Deadline 10/26/26
No salary listed
Senior
Bachelor's
Ho Chi Minh City, Vietnam
In Person
Biology & BiotechRegulatory & Quality (Life Sciences)

About the job

Requirements
  • Bachelor’s degree or higher in Veterinary Medicine, Pharmacology, Animal Science, Biology, or a closely related scientific field.
  • Minimum six years of Regulatory Affairs experience in pharmaceutical, veterinary, or biotechnology sectors.
  • Demonstrated experience engaging Vietnam’s competent animal health authorities and applying local veterinary medicinal-product registration, labeling, import/export, advertising, pharmacovigilance, and lifecycle compliance requirements.
  • Proven effectiveness in a highly matrixed multinational environment, including cross-border collaboration with regional/global regulatory hubs and peers.
  • Ability to work independently under tight timelines with minimal supervision.
  • Strong analytical and logical problem-solving capabilities.
  • Native Vietnamese and professional-level written and spoken English.
  • Regulatory Affairs Management.
  • Regulatory Compliance.
  • Regulatory Documents.
  • Regulatory Inspections.
  • Regulatory Processes.
  • Regulatory Strategy Development.
Responsibilities
  • Compile, review, translate, and submit registration dossiers for new biological and pharmaceutical products in accordance with local regulations, industry standards, and corporate guidelines.
  • Manage variations, extensions, and renewals of existing marketing authorizations to prevent supply-chain disruption or compliance gaps.
  • Serve as the primary regulatory contact for competent Vietnam animal health authorities and other relevant government bodies; manage submission follow-up, responses to authority questions, administrative issue resolution, and compliant working relationships.
  • Manage product-standard conformity declarations and product labels; coordinate with internal and external stakeholders to obtain and maintain required import and export permits.
  • Monitor, interpret, and communicate developments in local veterinary laws, standards, and regulatory trends to local and regional stakeholders.
  • Assess regulatory impact and support change-control processes. Review promotional, educational, digital, website, printed, and technical materials for alignment with local veterinary advertising requirements, global policies, and the company Code of Conduct. Provide documentation and advice for authority confirmation or submission, with operational ownership assigned under the approved local process.
  • Maintain complete, accurate, and inspection-ready regulatory records, approvals, licenses, labels, commitments, and supporting documentation throughout the product lifecycle.
  • Act as the designated Vietnam pharmacovigilance contact and maintain compliance with applicable global and local requirements.
  • Ensure timely intake, documentation, entry, follow-up, escalation, and reporting of adverse events and product complaints under applicable procedures and timelines.
  • Prepare, implement, and maintain local pharmacovigilance procedures; deliver required training to employees and relevant business partners; and conduct awareness sessions as needed.
  • Ensure appropriate pharmacovigilance clauses in relevant agreements and study or trial protocols; coordinate required Global Pharmacovigilance review and approval, train investigators or partners, and support safety-case entry and follow-up arising from post-marketing studies or other local activities.
  • Partner with regional and global pharmacovigilance teams on case management, compliance monitoring, reporting obligations, reconciliation, and corrective actions.
  • Liaise with Global Regulatory Affairs and the Regional Regulatory Affairs Lead to align Vietnam strategies with the global pipeline and provide visibility of local timelines and registration roadblocks.
  • Collaborate with Regulatory Affairs Managers in other markets to share intelligence, exchange technical strategies, benchmark timelines, and implement standardized tools that improve submission outcomes.
  • Partner with global chemistry, manufacturing, and controls and biological/pharmaceutical research and development teams to refine dossier quality before local submission and promote a first-time-right approach.
Desired Qualifications
  • Direct animal-health experience.

About the company

Merck develops prescription medicines, vaccines and veterinary treatments for patients, health systems and animal owners worldwide. Its vaccine portfolio includes Gardasil 9, which helps prevent cancers and other diseases caused by several types of human papillomavirus. The company takes potential treatments through laboratory research and clinical trials, then manufactures and sells approved products to drug distributors, hospitals, physicians and governments. Its animal health division sells medicines and vaccines to veterinarians, farmers and pet owners, while selected drug partnerships also earn shared profits or royalties. Founded in 1891, Merck is headquartered in Rahway, New Jersey.

Company Size

10,001+

Company Stage

IPO

Headquarters

Rahway, New Jersey

Founded

1891

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Simplify's Take

What believers are saying

  • U.S. employees build retirement benefits: Merck pairs a defined benefit pension with a matching 401(k).
  • Scientists work within a large research network: Merck reports approximately 24,700 employees in R&D.
  • Animal health adds growth: August 2026 results report Q2 sales of $1.8 billion, up 8% year over year.

What critics are saying

  • Job security faces cuts: Merck's active restructuring program eliminates roles and shrinks its global real estate footprint.
  • Keytruda protection narrows: its main U.S. patent expires in 2028, with additional patents expiring in 2029.
  • Revenue is concentrated: August 2026 results show Keytruda products generated $8.4 billion of Merck's $16.6 billion Q2 sales.

What makes Merck unique

  • Merck extends into farm technology: SenseHub continuously monitors livestock for behavioral and physiological changes.
  • Merck publishes open medical knowledge: its Manuals give clinicians and patients free online references.
  • Merck's donation commitment is open-ended: Mectizan supplies for river blindness continue for as long as needed.

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Benefits

  • Health Insurance
  • Dental Insurance
  • Vision Insurance
  • 401(k) Retirement Plan
  • 401(k) Company Match
  • Paid Vacation
  • Paid Sick Leave
  • Hybrid Work Options

Growth & Insights and Company News

6 month growth

-19%

1 year growth

-20%

2 year growth

-20%
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