Global Regulatory Strategic Platform Specialist

Global Regulatory Strategic Platform Specialist

Global Regulatory Strategic Platform Specialist

Opella

Workday

Bogota Cortezza

Hace 8 horas

Ninguna postulación

Sobre

Job title: Global Regulatory Strategic Platform Specialist Location: Bogotá 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. B Corp certified in multiple markets, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com. About the job: In this role, you will ensure compliance with local regulations for medicines, food supplements, and related products, while collaborating with global teams on challenging projects. This position offers the opportunity to work in a diverse, international environment, contribute to cross-country initiatives, and play a key role in maintaining product quality and safety. If you thrive in a fast-paced setting and enjoy working on impactful regulatory projects, we’d love to hear from you. Main Responsibilities Maintain regulatory compliance for medicines and food supplements across LATAM, including management of sanitary licenses and administrative changes. Prepare, submit, and track dossiers for product registration, renewals, and post-approval variations, ensuring alignment with local regulations. Conduct technical analysis of documentation, perform risk assessments, and address deficiency letters from health authorities promptly and accurately. Coordinate labeling updates and harmonization processes, including artwork evaluation, while minimizing regulatory and commercial impacts. Act as the primary point of contact for stakeholders (RSO, Global CMC, Global Labeling), ensuring effective communication and collaboration. Maintain regulatory databases and document management systems (e.g., VAULT RIM), ensuring data accuracy and timely updates. Stay informed about regulatory changes in LATAM and propose process improvements to enhance compliance and efficiency. Support transversal projects with global teams, fostering collaboration and knowledge sharing across regions. Requirements: Minimum of 3 years of experience in regulatory affairs for medicines and food supplements within LATAM markets. Bachelor’s degree in Pharmaceutical Chemistry or related field. Proactive, adaptable, and strong teamwork skills with a human-centered approach. Proficiency in managing regulatory dossiers, renewals, and administrative changes, with knowledge of systems such as VEEVA or similar. Able to comunicate in English proficiently - (B2 - C1). 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. Opella values diversity in all its forms and is committed to fostering a workplace where everyone can belong and excel. We welcome and encourage applications from people of all backgrounds. Join us on our mission. Health. In your hands. www.opella.com/en/careers 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. B Corp certified in multiple markets, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com. Privacy Notice