Regulatory Affairs Manager- Animal Health

Job description

Job Description

Primary Responsibilities (but not limited to) A.

Registration & Lifecycle Management New Product Approvals

Compile, review, translate, and submit high-quality registration dossiers for new biological and pharmaceutical products in accordance with local regulations, industry standards, and corporate guidelines.

Dossier Maintenance

Manage variations, extensions, and renewals of existing marketing authorizations to prevent supply-chain disruption or compliance gaps.

Health Authority Liaison

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.

Regulatory Operational Compliance

Manage product-standard conformity declarations and product labels; coordinate with internal and external stakeholders to obtain and maintain required import and export permits. B.

Regulatory Compliance & Technical Advisory Regulatory Intelligence

Monitor, interpret, and communicate developments in local veterinary laws, standards, and regulatory trends to local and regional stakeholders.

Change Control & Promotional Material Review

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.

Regulatory Records & Inspection Readiness

Maintain complete, accurate, and inspection-ready regulatory records, approvals, licenses, labels, commitments, and supporting documentation throughout the product lifecycle. C.

Pharmacovigilance (PV) Country Pharmacovigilance Contact

Act as the designated Vietnam PV contact and maintain compliance with applicable global and local requirements.

Safety & Product Complaint Reporting

Ensure timely intake, documentation, entry, follow-up, escalation, and reporting of adverse events and product complaints under applicable procedures and timelines.

PV Procedures & Training

Prepare, implement, and maintain local PV procedures; deliver required training to employees and relevant business partners; and conduct awareness sessions as needed.

PV in Agreements & Studies

Ensure appropriate PV clauses in relevant agreements and study or trial protocols; coordinate required Global PV review and approval, train investigators or partners, and support safety-case entry and follow-up arising from post-marketing studies or other local activities.

Regional & Global Coordination

Partner with regional and global PV teams on case management, compliance monitoring, reporting obligations, reconciliation, and corrective actions. D. Global, Regional & Cross-Border Collaboration Global & Regional Alignment: 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.

Process Optimization & Best-Practice Sharing

Collaborate with Regulatory Affairs Managers in other markets to share intelligence, exchange technical strategies, benchmark timelines, and implement standardized tools that improve submission outcomes.

Dossier Quality Harmonization

Partner with global CMC and biological/pharmaceutical R&D teams to refine dossier quality before local submission and promote a first-time-right approach.

Desired Experience/Education/Skills Education

Bachelor’s degree or higher in Veterinary Medicine, Pharmacology, Animal Science, Biology, or a closely related scientific field.

Experience

Minimum six years of Regulatory Affairs experience in pharmaceutical, veterinary, or biotechnology sectors; direct animal-health experience preferred.

Local Regulatory Expertise

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.

Matrix Collaboration

Proven effectiveness in a highly matrixed multinational environment, including cross-border collaboration with regional/global regulatory hubs and peers.

Work Style

Self-driven, detail-oriented, and able to work independently under tight timelines with minimal supervision.

Core Skills

Strong analytical and logical problem-solving capabilities; excellent cross-functional collaboration and negotiation skills.

Language

Native Vietnamese and professional-level written and spoken English.

Required Skills

Regulatory Affairs Management, Regulatory Compliance, Regulatory Documents, Regulatory Inspections, Regulatory Processes, Regulatory Strategy Development Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.

All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific.

Please, no phone calls or emails.

Employee Status

Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 10/26/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.