Associate Regulatory Affairs Manager - Abbott Nutrition Division

Job description

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. Working at Abbott 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. The Opportunity As the Associate Regulatory Affairs Manager, you will coordinate and document regulatory processes, such as inspections, license renewals, registrations and promo applications for Nutritional/Food and Medical Devices (40% of portfolio). You will compile and prepare materials for submission to regulatory agencies related to regulatory initiatives and maintain regulatory compliance of products through activities such as initial registrations, renewals, variations, promo permits, marketing materials review, and labeling review. You will also provide regulatory expertise to cross-functional teams and ensure compliance with Food and Drug Administration and National Dairy Authority regulations to support business continuity. What You’ll Do• Prepare quality regulatory dossiers for Food/Nutritional products, Drugs, and Medical Devices and submit within planned affiliate timelines. • Request and obtain regulatory documents required for local submissions. • Review clinical documentation to support product label claims. • Prepare and format dossiers to ensure compliance with local regulatory requirements. • Implement submissions and maintain appropriate regulatory archives. • Gain regulatory approvals from the Food and Drug Administration (FDA) and other relevant regulatory agencies to support product launches and product maintenance. • Provide quality responses to regulatory authorities within required timelines. • Complete regulatory approval processes and secure product licenses. • Communicate product approvals and maintain submission and approval records. • Perform regulatory responsibilities related to label and packaging development. • Ensure local label creation and packaging development meet local and corporate requirements while supporting business needs. • Prepare periodic regulatory reports covering submissions and approvals for local management. • Serve as Regulatory Lead for New Product Introduction (NPI) project meetings for assigned products. • Maintain compliance of marketed products with local and corporate regulatory requirements, including labeling, label change management, and registered chemistry and manufacturing commitments. • Conduct compliance self-audits to identify potential compliance issues. • Review promotional materials in accordance with established policies. • Complete Global and/or Regulatory Core Curriculum and Good Regulatory Practices training. • Keep abreast of regulatory updates, changes, and trends that may impact the business environment and communicate implications to relevant stakeholders. • Maintain and strengthen communication with the Food and Drug Administration (FDA), National Dairy Authority (NDA), and industry associations. Requirements• Minimum 5 years of experience performing regulatory affairs responsibilities within the Food Industry, Pharmaceutical, and/or Medical Device industries, with at least 2 years at a supervisory or specialist level. • Experience with FDA Center for Food regulations preferred. • In-depth knowledge of local regulations pertaining to product registration requirements in the Center for Food. • Knowledgeable in Microsoft Word, Excel, PowerPoint, and Adobe Acrobat Professional. • Strong written and spoken English communication skills. • Competent project management skills. • Ability to handle multiple activities simultaneously. • Strong analytical skills with accuracy, reliability, and attention to detail. • Graduate of B.S. Food Technology, Nutrition/Community Nutrition, Pharmacy, Industrial Pharmacy, or allied courses. Location: This position is based in Philippines. Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal. The base pay for this position is N/AIn specific locations, the pay range may vary from the range posted. JOB FAMILY:Regulatory Operations DIVISION:AN Abbott Nutrition LOCATION:Philippines > Taguig City : Venice Corporate Center ADDITIONAL LOCATIONS: WORK SHIFT:Standard TRAVEL:Not specified MEDICAL SURVEILLANCE:Not Applicable SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)