Job Location : Columbus,OH, USA
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.Manager Regulatory AffairsAbout AbbottAbbott 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.Position SummaryAs an individual contributor, the function of a Regulatory Affairs Manager is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual will execute tasks and play a consultative role by partnering with cross-business functions. The individual is responsible for compliance with applicable corporate and divisional policies and procedures and regulatory SOPs.WHAT YOU'LL DOInterpret and apply regulatory requirements for the United States pediatric nutrition business, including those relevant to infant formula.Understand the business environment, the regulatory environment, and pertinent regulations. Use knowledge to conduct regulatory assessments, formulate regulatory strategy, advise teams, and implement organizational plans to ensure compliance and successful marketing of nutritional products.Participate as a team member in product innovation to build product pipeline. Provide technical leadership to business units, commit to team goals, and effectively communicate regulatory position. May lead cross-functional project teams.Communicate project status, regulatory requirements, regulatory timelines, and other pertinent information to the regulatory affairs teams, core functional teams, and other cross-functional colleagues.Author infant formula notifications for submission to US FDA.Assess product claims for regulatory compliance and assist in identifying data needed to support claims.Review and approve product labels, advertising, and promotional items for regulatory compliance.Review technical documentation for regulatory compliance.Review external communications for regulatory compliance.Assess emerging regulations for business impact and make recommendations for external and internal consideration based on assessment.Where applicable, determine and communicate dossier requirements for novel ingredients.EDUCATION AND EXPERIENCE, YOU'LL BRING:RequiredMS or PhD degree in Human Nutrition, Dietetics, Biological Science, or related.5+ years executing and managing technical and scientific regulatory activities, or related.Must function independently as a decision-maker on regulatory issues, be able to organize and track complex information, collaborate and communicate with others, and assure that deadlines are met.Excellent writing skills, specifically the competency to communicate scientific and/or technical information to internal and external audiences through clear, concise, and thorough writing.Ability to follow and develop scientific arguments.Experience serving as subject matter expert and/or regulatory lead on cross-functional teams such as those for new product development, process improvement, and business maintenance.Willingness to work both independently and in partnership with others.Proficiency using various forms of communication (email, PowerPoint slides, virtual meetings, in-person meetings, presentations, etc.) and information sharing/management systems.Self-driven to take initiative.High level of attention to detail.Analytical thinking skills.Ability to manage projects.PreferredExperience with clinical studies and/or working in a clinical setting.Knowledge of United States regulations relating to foods/nutritional products.Experience working with regulatory agencies and/or trade associations.Experience defining regulatory strategy.Knowledge of principles and requirements of promotion, advertising, and labeling.MISC:This is an onsite role (not a remote role).Apply NowThe base pay for this position is $95,000.00 – $190,000.00. In specific locations, the pay range may vary from the range posted.#J-18808-Ljbffr