We are seeking a highly experienced and technically grounded Product Development Manager & Regulatory Affairs professional to lead our health supplement portfolio across international markets. In this dual-function role, you will drive product development from ideation and formulation through to commercialization, working closely with R&D, formulation scientists, and our in-house manufacturing facility to ensure that product design, ingredients, and claims are fully aligned with the regulatory requirements of each target country. Beyond internal collaboration, you will actively cultivate relationships with regulatory authorities and in-country agents across markets to facilitate and accelerate product registration timelines. You will act as the critical link between technical development, in-house manufacturing, and international regulatory strategy ensuring every product is innovative, commercially viable, and approved efficiently in every market it enters.
Responsibilities:
Product Development
- Lead end-to-end product development for health supplement portfolios, from concept ideation and formulation brief to final product launch across international markets.
- Serve as the primary liaison between the commercial team and technical/R&D team, translating market needs and regulatory requirements into actionable product development briefs.
- Collaborate closely with R&D teams to evaluate and select ingredients, dosage forms, and product formats that comply with country-specific regulations.
- Review formulation proposals and technical documentation to ensure ingredient lists, dosages, and health claims are aligned with the regulatory framework of each target market before development proceeds.
- Work closely with in-house factory teams including production, quality assurance, and process engineering to ensure technical feasibility and on-time delivery.
- Support comprehensive product technical dossiers, specifications, and claims substantiation packages.
Regulatory Affairs
- Ensure all health supplement products comply with applicable regulations in target markets (e.g., US FDA, EU EFSA, ASEAN, China NMPA, Australia TGA, and other relevant authorities).
- Prepare, review, and submit regulatory dossiers, product registrations, notifications, and renewals as required by each jurisdiction.
- Interpret and apply evolving international regulations related to health supplements, nutraceuticals, and functional foods.
- Build and maintain direct relationships with regulatory authorities and government agencies in each target country, proactively engaging to facilitate smoother and faster product registration processes.
- Develop country-specific regulatory strategies and submission timelines, leveraging established relationships with local regulatory contacts to reduce registration lead times.
- Act as the primary point of contact for in-country regulatory agents, distributors, and local consultants, coordinating closely to resolve queries, track submission status, and accelerate approvals.
- Review and approve all labeling, claims, and marketing materials for regulatory compliance.
- Maintain and update a global regulatory intelligence database to proactively track legislative changes.
- Advise internal stakeholders on regulatory risks and develop mitigation strategies for new market entries.
- Lead regulatory due diligence activities for new product development, acquisitions, or partnerships.
Qualifications:
- Bachelor's degree required in Life Sciences, Pharmacy, Food Science, Biochemistry, Nutrition, or a related field. Master's degree or MBA is preferred, particularly with a focus on regulatory affairs, product management, or international business.
- Minimum 5–8 years of experience in product management and/or regulatory affairs within the health supplement, nutraceutical, pharmaceutical, or functional food industry.
- Exposure to e-commerce and digital health supplement channels. Prior experience in a multinational or regional FMCG/healthcare company. Experience in markets such as Southeast Asia, China, Middle East, or USA is a strong advantage.
- Demonstrated experience managing product registrations and regulatory submissions across multiple international markets.
- Track record of successfully launching health supplement products from concept to market.
- Experience working with contract manufacturers (CMOs) and managing complex cross-functional projects.
- Strong knowledge of global health supplement regulations (FDA DSHEA, EU Food Supplement Directive, CODEX Alimentarius, GMP standards, etc.).
- Proficiency in regulatory submission platforms and document management systems.
- Understanding of ingredient safety assessments, clinical substantiation, and health claim regulations.
- Experience with product labeling requirements and compliance review processes.
- Familiarity with GMP, ISO, and quality assurance standards applicable to dietary supplements.
- Excellent project management skills with the ability to manage multiple priorities in a fast-paced, international environment.
- Strong analytical and critical thinking skills; ability to interpret complex regulations and translate them into actionable business guidance.
- Outstanding written and verbal communication skills in English; proficiency in additional languages is a strong advantage.
- Highly collaborative with strong stakeholder management capabilities across cultures and time zones.
- Entrepreneurial mindset with a bias for action and a commitment to quality.
