Regulatory Affairs Manager

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About the role

JOB DESCRIPTION: Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands, including Similac®, PediaSure®, Pedialyte®, Ensure® and Glucerna®, to help get the nutrients they need to live their healthiest life. At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to: • Career development with an international company where you can grow the career you dream of. • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. As the Regulatory Affairs Manager, you will coordinate, document and complete regulatory processes, such as inspections, license renewals, or registrations. You will compile and prepare materials for submission to regulatory agencies related to regulatory initiatives for Food/Nutrition, Drug and Medical Device portfolios. You will maintain regulatory compliance of products for lifecycle activities including initial registrations, variations, promotional permits, labeling reviews, and other regulatory requirements to ensure compliance with FDA regulations and business continuity. You will actively collaborate with cross-functional teams including Supply Chain, Marketing, Medical Affairs, and Quality Assurance, while serving as the Lead NPI Representative for Abbott Nutrition Regulatory Affairs and providing regulatory expertise to support launch activities. What You’ll Do • Prepare high-quality regulatory dossiers for Food/Nutritional, Drug, and Medical Device products and submit them within planned timelines. • Request and obtain regulatory documents required for local submissions. • Prepare and format dossiers to meet local regulatory requirements. • Review labeling materials to ensure compliance with applicable regulations. • Implement submissions and maintain appropriate regulatory archives. • Secure FDA and other regulatory agency approvals to support product launches and product maintenance. • Provide quality responses to regulatory authorities within required timelines. • Complete regulatory approval processes and obtain product licenses. • Communicate product approvals and maintain submission and approval records. • Support label and packaging development activities and ensure compliance with local and corporate requirements. • Prepare monthly regulatory reports and communicate status updates to management. • Lead regulatory activities for NPI projects and collaborate with cross-functional teams on launch requirements. • Maintain compliance of marketed products with local and corporate regulatory requirements. • Conduct compliance self-audits and complete required regulatory training programs. • Monitor regulatory updates, changes, and trends that may impact the business environment and communicate implications to stakeholders. • Build and maintain relationships with regulatory authorities and industry associations. Requirements • Minimum 8 years of experience performing regulatory affairs responsibilities within the Food Industry, Medical Device, and/or Pharmaceutical industry. At least 4 years should be at a supervisory or specialist level. Experience in Food and Food Suppleme

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