Regulatory & Scientific Communications Manager

Opella is the self-care challenger with the purest and **third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally**.   Our mission is to bring health in people’s hands by **making self-care as simple as it should be**. For half a billion consumers worldwide – and counting. At the core of this mission is our **100 loved brands**, our **11,000-strong global team, our 13 best-in-class manufacturing sites** and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. **As a globally certified B Corp company,** we are active players in the journey towards healthier people and planet. Find out more about our mission at [www.opella.com](http://www.opella.com). **_Join us on our mission. Health. In your hands_** **JOB PURPOSE** Develop and execute regulatory strategy and operations in Vietnam, ensuring full compliance with local regulations while enabling timely product registrations, lifecycle management, regulatory intelligence, regulatory risk management and promotional & non-promotional review **for assigned portfolio** to ensure compliance with local regulations and Opella SOP. Provide scientific and claims support to ensure all product communications (including on pack claims, Health Care Professionals (HCP) and Consumer communications) are substantiated, compliant, and aligned with both regulatory requirements and business objectives **for assigned portfolio/projects.** Coordination of medical strategies developed by Medical Leads to support HCP engagement and executing key HCP initiatives for Vietnam market. **KEY ACCOUNTABILITIES** **Regulatory Strategy, Operations & Compliance** * Develop and implement local regulatory strategies for new product registration, switches, lifecycle management, and portfolio expansion in Vietnam in line with business objectives * Lead end-to-end regulatory activities including dossier preparation, submission, approval tracking, and response to authority queries (e.g., DAV/MOH/VFA) * Ensure high-quality regulatory submissions within agreed timeline for all regulatory deliverables to support product launches and business continuity * Maintain compliance of all marketed products through lifecycle management (renewals, amendments/variations, labeling/packaging updates) and CMC coordination with manufacturing sites for assigned portfolio * Monitor new regulatory requirements and assess impact on existing and pipelining products for entire Vietnam product portfolio * Serve as risk focal point to identify, assess, and mitigate regulatory risks, providing clear recommendations to cross-functional stakeholders and communication with key stakeholders and update of Opella Risk Management Database for Vietnam * Review and approve promotional and non-promotional materials in line with local regulations and Opella SOPs including cross functional review coordination, claims substantiation and approval tracking * Ensure compliance and regulator tracking of regulatory registration database within Opella * Act as primary local regulatory contact with Health Authorities and build strong relationships with authorities to: * Support the business during regulatory authority inspections * Build and maintain trust-based relationships with local health authorities * Negotiate solutions with regulatory decision-makers in the best interests of Opella and Vietnamese consumers. **Claims & Scientific Support:** * Lead review and validation of product claims (on-pack, advertising, digital, HCP materials) to ensure: * Scientific substantiation * Regulatory compliance * Collaborate with global, R&D, and brand teams to localize claims for Vietnam market * Evaluate supporting evidence and ensure all claims are adequately documented and audit-ready * Provide scientific input to ensure accuracy and consistency of product communications across consumer and professional channels * Support development of claims frameworks aligned with local regulatory expectations and business objectives. **Scientific engagement Support** * Coordinate Science Formula Strategies defined by Medical Leads for Vietnam market * Support execution of key Scientific Communication initiatives (e.g., educational materials, scientific events) * Review HCP-facing materials to ensure scientific accuracy and regulatory compliance * Facilitate alignment between regulatory, medical, brand, and commercial teams to ensure compliant execution. **Others:** * Support operational processes including vendor management, PO creation, and budget tracking activities * Ensure proper documentation and traceability of regulatory and claims decisions * Contribute to continuous improvement of regulatory and claims review processes * Administrative and Opella Regulatory and relevant medical database management and document control and archiving for Vietnam. **ABOUT YOU** **Education:** * Degree in Medicine, Pharmacy, Pharmaceutical Sciences, life sciences or related fields * Registered with the local health care professional association with a valid licence (e.g., Pharmacist, Doctor) **Experience:** * Minimum 10 years of Regulatory Experience **Qualification:** * Strong understanding of Vietnam consumer healthcare related regulations and Health Authority requirements, such as cosmetics, nutraceuticals and pharmaceuticals * Strong understanding of the consumer healthcare and pharmaceutical industry, product development, and R&D processes * Experience in Vietnamese regulatory environment and health authority and VN HCP interactions * Experience in regulatory submission, product registration and HA interactions, medical operations, budget management and event coordination * Experience in engagement tracking systems and HCP engagement compliance * Demonstrated success in partnering and influencing across a matrix organization * Familiarity with Opella systems and tools is an advantage. **WHY US?** At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day. **We Are Challengers.** We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things: **All In Together**: We keep each other honest and have each other's backs. **Courageous**: We break boundaries and take thoughtful risks with creativity. **Outcome-Obsessed:** We are personally accountable, driving sustainable impact and results with integrity. **Radically Simple:** We strive to make things simple for us and simple for consumers, as it should be.