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:
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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.