Description

Abbott Laboratories is seeking a Regulatory Affairs Project Manager – Nutrition to lead regulatory projects supporting our global nutrition portfolio from Columbus, OH or Abbott Park, IL. In this role, you will plan and manage regulatory submission timelines, coordinate cross-functional teams, and ensure compliance with FDA, EU, and international nutrition regulations. You will prepare and review dossiers, labeling, and change controls, assess regulatory risk, and support product launches. Abbott offers an inclusive, mission-driven culture with strong development opportunities and competitive benefits.
Lead and manage regulatory projects for Abbott’s nutrition portfolio
Plan and track regulatory submission timelines and deliverables
Coordinate cross-functional teams across R&D, Quality, Clinical, and Marketing
Prepare, review, and submit regulatory dossiers, variations, and responses
Ensure product and labeling compliance with FDA, EU, and global nutrition regulations
Support new product launches and product changes from a regulatory perspective
Assess and communicate regulatory risks and mitigation strategies
Maintain accurate regulatory documentation and systems
Monitor evolving regulations and advise stakeholders on impact
Contribute to process improvements and best practices in regulatory affairs
Regulatory submissions (FDA, EU, international)
Nutrition and labeling regulations
Project management
Risk assessment and mitigation
Regulatory strategy development
Cross-functional collaboration
Technical documentation and dossier preparation
Data analysis and interpretation
Timeline and stakeholder management
Regulatory information systems (RIM/trackers)
Medical Insurance
Dental Insurance
Vision Insurance
Life Insurance
401k
Regulatory Affairs Certification (RAC) preferred
Project Management Professional (PMP) or equivalent a plus
Knowledge of FDA, EU and international nutrition regulations