Regulatory Affairs Manager

Prestige Brands•Tarrytown, NY

1d•$125,000 - $140,000•Hybrid

About The Position

The Regulatory Affairs Manager is responsible for U.S. regulatory strategy, compliance, and lifecycle management for assigned medical device and over-the-counter (OTC) drug products. The role serves as the primary Regulatory Affairs partner for assigned product portfolios and provides timely, practical guidance across product development, labeling and claims, manufacturing and supplier changes, quality-system activities, and ongoing FDA compliance. It requires strong working knowledge of U.S. medical device requirements, including Class I and 510(k)-exempt devices, and OTC drug requirements, including applicable OTC monographs and administrative orders. This is a hands-on role requiring independent regulatory judgment, cross-functional partnership, and management of multiple priorities in a consumer healthcare environment. The Manager independently manages assigned portfolios and escalates significant regulatory issues to the Director. The role develops practical regulatory strategies supporting compliant product maintenance, innovation, and growth; reviews labeling, claims, advertising, promotional materials, and e-commerce content; maintains FDA compliance and product lifecycle documentation; assesses product and operational changes; and partners with Quality and other functions on quality-system activities. The role also represents Regulatory Affairs on cross-functional teams, supports external partners, and improves procedures, tools, trackers, and training. The position follows a hybrid schedule, with work in the Tarrytown office Tuesday through Thursday and remote work Monday and Friday. Travel is 5%. The stated salary range for the Manager level is $125,000–$140,000. Applicants must be authorized to work for any U.S. employer; visa sponsorship is unavailable.

Requirements

Bachelor’s degree in a scientific, engineering, pharmacy, health-related, or other relevant discipline.
Direct U.S. Regulatory Affairs experience with medical devices.
Demonstrated experience independently managing assigned products or portfolios through development, commercialization, and post-market lifecycle activities.
Experience working in a cross-functional, matrixed environment and communicating regulatory decisions to technical and non-technical stakeholders.
Strong working knowledge of U.S. medical-device requirements, particularly Class I devices, 510(k) exemptions, establishment registration, device listing, labeling, quality-system expectations, and change assessments.
Strong working knowledge of U.S. OTC monograph drug requirements, including Drug Facts labeling, applicable monographs and administrative orders, FDA drug registration and listing, NDC-related maintenance, and annual certification obligations.
Experience reviewing claims and substantiation, labeling, advertising, promotional materials, and digital/e-commerce content.
Ability to assess product, process, supplier, specification, component, and labeling changes and clearly document regulatory rationale and required actions.
Working knowledge of quality-system interfaces, including change control, complaints, CAPA, risk management, document control, and CMO/supplier oversight.
Strong written and verbal communication, organization, prioritization, and follow-through skills.
Ability to work independently, exercise sound regulatory judgment, manage competing deadlines, and provide clear, business-focused recommendations.
Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, and electronic document or quality systems.
Ability to read, analyze, and interpret business periodicals, professional journals, technical procedures, and governmental regulations; write reports, business correspondence, and procedure manuals; and present information and respond to questions.
Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume, and apply basic algebra and geometry.
Ability to apply common-sense understanding to instructions furnished in written, oral, or diagram form and deal with problems involving several concrete variables in standardized situations.
Must be authorized to work for any employer in the U.S.; the company is unable to sponsor or take over sponsorship of an employment visa.
Must be able to work in the Tarrytown office Tuesday, Wednesday, and Thursday, with remote work Monday and Friday.
Ability to travel 5% by car, plane, or rail.

Nice To Haves

Advanced degree.
Experience with OTC drug products is strongly preferred.
Experience managing products across both medical device and OTC drug regulatory frameworks is a plus.

Responsibilities

Serve as the primary U.S. Regulatory Affairs lead for assigned medical device and OTC drug products and develop practical regulatory strategies for product maintenance, innovation, and growth.
Independently manage assigned portfolios, provide regulatory recommendations, identify risks and options, and escalate significant issues with proposed paths forward to the Director.
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 regulatory pathways and documentation needs.
Maintain compliance for assigned OTC monograph drugs, including establishment and drug listing activities, labeler-code/NDC information, annual certifications, and supporting regulatory records.
Maintain medical-device regulatory obligations, including establishment registration, device listing, classification assessments, and documentation supporting 510(k)-exempt status or required premarket strategy.
Monitor relevant FDA regulations, OTC monograph administrative orders, guidance, and industry developments; assess business impact and communicate required actions.
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 evaluation of CMO and supplier changes, product transfers, and other significant lifecycle activities.
Represent Regulatory Affairs on assigned brand, innovation, supply, quality, and commercialization teams; establish realistic timelines and deliver regulatory work on schedule.
Build working relationships across functions and with external manufacturers, suppliers, laboratories, and consultants.
Develop or improve procedures, tools, trackers, and training that strengthen compliance, transparency, and efficient portfolio management.