Prestige Consumer Healthcare is a company that focuses on product innovation and quality in the over-the-counter healthcare and women’s health categories to better improve the lives of our customers and their world. For generations, our trusted brands have helped consumers care for themselves and their loved ones. We are the largest independent provider of over-the-counter products in North America, and we are constantly improving and creating products that match the ever-changing lifestyles and needs of people and families everywhere.
JOB SUMMARY:
The Regulatory Affairs Manager is responsible for U.S. regulatory strategy, compliance, and lifecycle management for assigned medical device and over-the-counter drug products. The position serves as the primary Regulatory Affairs partner for assigned product portfolios and provides practical, timely guidance across product development, labeling and claims, manufacturing and supplier changes, quality-system activities, and ongoing FDA compliance. The role requires strong working knowledge of U.S. medical device requirements, including Class I and 510(k)-exempt devices, as well as OTC drug requirements, including applicable OTC monographs and administrative orders. This is a hands-on role requiring independent regulatory judgment, strong cross-functional partnership, and the ability to manage multiple priorities in a consumer healthcare environment.
MAJOR RESPONSIBILITES/ACTIVITES:
Portfolio ownership and regulatory strategy (25%) Serve as the primary U.S. Regulatory Affairs lead for assigned medical device and OTC drug products and develop practical regulatory strategies that support compliant product maintenance, innovation, and growth. At the Manager level, independently manage assigned portfolios and escalate significant regulatory issues to the Director. At the Sr. Manager level, lead broader or more complex portfolios and the development and execution of strategies for significant regulatory issues, in consultation with the Director.
Provide clear regulatory recommendations, identify risks and options, and escalate significant issues with proposed paths forward.
Labeling, claims, advertising, and product development (25%) Review product labeling, Drug Facts, device labeling, packaging, claims, advertising, promotional materials, and e-commerce content for compliance and adequate substantiation.
Partner with Marketing, Legal, Medical/Clinical, Product Development, Package Development, and Graphics from concept through commercialization.
Assess new products, line extensions, formula or material changes, and claim changes to determine the appropriate regulatory pathway and documentation.
FDA compliance and lifecycle maintenance (20%) Maintain compliance for assigned OTC monograph drugs, including applicable establishment and drug listing activities, labeler-code/NDC information, annual certifications, and supporting regulatory records.
Maintain medical-device regulatory obligations for assigned products, including establishment registration, device listing, classification assessments, and documentation supporting 510(k)-exempt status or any required premarket strategy.
Monitor relevant FDA regulations, OTC monograph administrative orders, guidance, and industry developments; assess business impact and communicate required actions.
Change control, technical documentation, and quality-system support (20%) Provide documented regulatory impact assessments for formula, specification, supplier, CMO, manufacturing process, component, packaging, labeling, and distribution changes.
Maintain or oversee regulatory sections of product technical files and ensure regulatory decisions, claims support, and product status documentation are current, controlled, and retrievable.
Partner with Quality on change controls, deviations, complaints, CAPAs, recalls or corrections, risk-management activities, quality agreements, and regulatory inspection readiness, as applicable.
Support regulatory…