Global Regulatory Affairs Manager (Dietary Supplements)
hace 2 días
City of London
Job Title: Global Regulatory Affairs Manager (Dietary Supplements) Location: Hybrid/ Remote Working Hours: Part-time, Freelancer or on a Consultant basis Industry: Wellness and Longevity Salary: £45k- £75k depending on experience About Us: At NADclinic, we’re proud to be an innovative, forward-thinking and truly transformational company that gives our clients the opportunity to ‘be their best self’. With a team of medical professionals specialising in nutrition, neurology and complementary therapies, we aim to improve psychological and physical health and performance. We do this through harnessing the unique power of essential and life-changing NAD+, a molecule that helps our cells produce energy, and which can mitigate the debilitating effects of ageing, illness and chronic conditions. Role Overview: We are seeking a highly skilled and self-driven Global Regulatory Affairs Manager to lead our global product compliance, labelling, and certification strategy. This role ensures that all NAD supplements and wellness products meet regulatory, quality, and import/export requirements across international markets. You will serve as the company’s subject matter expert on regulatory affairs, managing market registrations, certifications, and packaging compliance while also overseeing trade, ethical, and quality compliance across our global operations. Key Responsibilities 1. Global Packaging & Labelling Compliance • Research, interpret, and implement current and emerging packaging and labelling regulations for dietary supplements and nutraceuticals in EU (under foodstuff regulations), UK (MHRA), US (FDA), Canada (NHPD), and other target markets (e.g., Australia, GCC, APAC)., • Lead the review and approval of all packaging artwork, ensuring 100% compliance with ingredient listings, nutrition/supplement facts, health claims, allergen declarations, and mandatory markings., • Develop and maintain detailed packaging guidelines, templates, and checklists tailored for each market., • Collaborate with Marketing and Design teams to ensure compliant branding and claim language. 2. Product Registration & Certifications • Manage the end-to-end process of obtaining and renewing product registrations, notifications, and Free Sale Certificates (FSCs)., • Liaise with government bodies, chambers of commerce, ministries of health, and third-party agencies to secure necessary documentation for market access., • Maintain an organised database of all certifications, licenses, and renewal timelines., • Advise management on regulatory classifications (e.g., supplement, nutraceutical, or medicinal) based on jurisdictional requirements. 3. Import/Export & Trade Compliance • Prepare and manage documentation required for customs clearance, import/export licensing, and shipment approvals., • Work closely with logistics partners and distributors to ensure smooth international product movement., • Anticipate and mitigate potential import/export challenges by ensuring all necessary permits and authorisations are secured in advance., • Support the Supply Chain team in aligning trade operations with global regulatory standards. 4. Risk Management & Quality Oversight • Monitor and evaluate compliance risks related to labelling, advertising, and product claims., • Conduct internal audits and implement corrective or preventive actions where needed., • Ensure adherence to GMP, GCP, ISO, and relevant supplement or nutraceutical manufacturing standards., • Promote ethical and transparent marketing and business conduct throughout the organisation. 5. Regulatory Intelligence & Market Expansion • Continuously track changes in global regulatory frameworks affecting dietary supplements and related products., • Assess the impact of new or evolving regulations on existing and upcoming products., • Develop and communicate compliance strategies to leadership for market entry and ongoing operations., • Build and maintain strong relationships with international regulatory consultants and agencies. 6. Documentation, Dossiers & Cross-Functional Collaboration • Compile and maintain comprehensive technical product dossiers, including formulation details, certificates of analysis, safety data, and claim substantiation., • Ensure all product claims are scientifically supported and regionally compliant., • Serve as the key regulatory advisor for internal teams (Product Development, Marketing, Quality, Sales, and Supply Chain)., • Provide clear, practical guidance to non-regulatory stakeholders on requirements and risk management. Qualifications & Experience • Bachelor’s degree in Life Sciences, Food Science, Chemistry, Pharmacy, or Regulatory Affairs (Master’s preferred)., • 5–7+ years of experience in regulatory or compliance roles within dietary supplement, nutraceutical, or functional food industries., • Demonstrable experience managing product registrations and labelling compliance in the EU, UK, US, and preferably Middle Eastern markets., • Strong working knowledge of frameworks such as FDA 21 CFR Part 101, EU FIC Regulation, MHRA guidelines, SFDA, and GCC supplement laws., • Proven success securing FSCs and product approvals across multiple regions., • Familiarity with import/export compliance documentation and regulatory trade requirements. Skills & Competencies • Meticulous attention to detail with precision in interpreting complex regulatory texts and reviewing artwork., • Analytical and research-oriented and have a strong ability to navigate evolving international regulations., • Project management excellence and capable of managing multiple concurrent projects and deadlines., • Strong communicator who can clearly translate regulatory information into actionable business guidance., • Autonomous and proactive in anticipating challenges and independently drives solutions. In addition to working within an exceptionally driven team and contributing to our client experience, we have a number of excellent benefits to reward you for your hard work. • 20/25 days holiday (in addition to Bank Holidays), • Contributory Pension Scheme, • Employee Assistance Programme Service., • Health and Dental schemes after 1 year of service., • Free Blood Test & Consultation by our clinic Doctor in your first week., • Free Infusion after passing your probation, and 1 every quarter (3 months) following this., • 50% Friends & Family Discount.