Regulatory Affairs Manager

Our strategic partner specializes in supplying ingredients, additives, and related commodities for various manufacturing industries. The business is currently expanding its operations in Vietnam and is seeking multiple new positions to support its growth strategy and business expansion in the next development phase.

Location: Ho Chi Minh City, Vietnam

Summary

Our strategic partner is seeking a Regulatory Affairs Manager to lead enterprise-wide regulatory governance across pharmaceutical and other regulated product portfolios. The role combines deep pharmaceutical regulatory expertise with cross-domain compliance oversight, lifecycle and change control, regulatory risk management, business advisory, inspection and recall response, and internal RA capability development.

Job Responsibilities

• Monitor, interpret, and implement applicable regulations covering medicinal materials, food-production ingredients, animal feed, veterinary medicines, chemicals, and fertilizers.
• Establish a regulatory landscape map for each product category and act as the regulatory owner across the full Food and Non-Food portfolio.
• Oversee and assess registration dossiers for pharmaceutical ingredients, including renewals, variations, and supplementary submissions.
• Maintain regulatory control over pharmacopeial requirements, quality specifications, and testing methods applicable to pharmaceutical products.
• Lead regulatory activities during inspections, product recalls, and legal or compliance incidents involving pharmaceutical products.
• Provide compliance direction for food ingredients, animal feed, veterinary products, chemicals, and fertilizers, including product classification, regulatory routes, and areas where different legal frameworks overlap.
• Escalate specialized regulatory matters to the appropriate domain RA specialist when deeper subject-matter support is required.
• Assess regulatory implications arising from changes to ingredients, suppliers or manufacturers, and intended product use, and establish RA review and Regulatory Impact Assessment (RIA) before significant changes are implemented.
• Advise Procurement, Logistics, Sales, and Business Development teams on regulatory requirements and participate in go-to-market decisions and product portfolio reviews.
• Ensure business expansion and commercial activities remain within the applicable legal and regulatory scope.
• Serve as the primary RA contact for multi-agency inspections, product recalls, and safety or compliance incidents, coordinating with regulators and external legal or advisory parties when necessary.
• Act as the enterprise Regulatory Affairs subject-matter expert, develop multi-domain internal RA training, and mentor RA staff and key users in other functions.

Job Requirements

• Bachelor’s degree in Pharmacy or a higher pharmacy qualification is required.
• A pharmacy practice certificate is strongly preferred and is required where the position also assumes the relevant professional-responsibility function.
• 7-10 years of Regulatory Affairs experience in the pharmaceutical industry.
• 3-5 years of experience at Senior, Lead, or Manager level.
• Experience extending beyond pharmaceuticals into at least one additional regulatory domain: food, chemicals, or veterinary products/animal feed.
• Deep understanding of the pharmaceutical legal and regulatory framework, pharmacopeial requirements, and quality standards.
• Ability to rapidly learn and oversee multi-domain regulatory requirements, manage regulatory risk at a system level, and provide strategic RA leadership.
• Strong systems thinking and ability to work effectively across multiple regulatory domains.
• Ability to translate legal and regulatory requirements into clear business implications and practical guidance.
• Decisive yet prudent judgment, with high integrity and professional independence.

If you possess the required skills and experience and are ready to significantly contribute to the dynamic team, we warmly welcome your application at thanh.nguyen@peoplewise.vn or application@peoplewise.vn.

About PeopleWise Vietnam:

PeopleWise Vietnam is founded on the belief that people are at the core of organizational success. We provide comprehensive human resources consulting services to partners worldwide, including Executive Search and Talent Acquisition Solutions, Staffing Management Solutions, and People & Organizational Consulting Services.

We are proud to work with multinational corporations as well as leading local and foreign-invested enterprises, helping them build high-performing teams and achieve sustainable business growth. Our commitment is to deliver high-quality, cost-effective people solutions that create lasting competitive advantages and long-term value for both our clients and candidates.

To help you explore even more career opportunities, we invite you to join PeopleHays, our career platform, at https://peoplehays.com.

To learn more about PeopleWise Vietnam and our services, please visit https://peoplewise.vn/.