Sr. Manager, Regulatory Affairs

Position: Sr. Manager Regulatory Affairs North America

Reports to: Sr. Director Regulatory Affairs North America

Location: Piscataway, NJ, United States

Position Summary

The Senior Regulatory Affairs Manager leads regulatory strategy and compliance for the Oral Care and Personal Care divisions. This critical leadership position drives the regulatory activities necessary for maintaining existing commercialized products as well as the strategic development and introduction of new products across the U.S. and Canada. Additionally, this position provides strategic support for high-priority projects within the Home Care category as business needs dictate.

Key Responsibilities

• Regulatory Strategy: Lead and implement comprehensive regulatory strategies and compliance activities for Oral and Personal Care product categories, spanning cosmetics, drugs, and medical devices, ensuring strict adherence to applicable U.S. FDA and Health Canada regulations.

• Submissions & Government Interactions: Oversee and prepare complex regulatory submissions to the FDA, including 510(k)s, NDAs, and ANDAs, serving as a primary liaison and point of contact for interactions with health authorities.

• Cross-Functional Collaboration: Partner with cross-functional stakeholders to accelerate new product development projects, and gather necessary information for product and site registrations, notifications, and reporting obligations.

• Regulatory Intelligence: Monitor, analyze, and interpret evolving regulatory requirements, policies, and guidelines. Assess potential business impacts and proactively prepare strategic communications for internal stakeholders.

• Chemical & Material Compliance: Monitor federal and state restrictions for Chemicals of High Concern, assessing and mitigating the impact on the product portfolio.

• Quality & Change Control: Review and approve change controls and Tech Transfer checklists to accurately assess the scope and impact of changes, recommending the most appropriate implementation plans.

• Process Optimization: Review, update, and author Work Instructions and Standard Operating Procedures (SOPs) to formalize processes and establish best practices that guarantee ongoing compliance, driving cross-functional alignment and clear roles and responsibilities.

• Risk Assessment: Review product claims against applicable regulatory requirements and provide comprehensive risk assessments.

• Efficiencies & Innovation: Leverage AI tools and drive digital adoption to increase operational efficiencies and streamline workflows within the department.

• People Management: Manage, mentor, and coach direct reports, providing strategic guidance, performance feedback, and developmental support to cultivate a high-performing team.

Required Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or a closely related scientific field.

• Minimum of 10 years of progressive experience in regulatory affairs within the consumer goods or pharmaceutical industry.

• Comprehensive, expert-level knowledge of U.S. regulations pertaining specifically to cosmetics and drugs.

• Excellent people management and leadership skills, with demonstrated experience effectively managing and developing direct reports.

• Proven track record of independently preparing, managing, and submitting successful regulatory documents.

• Strong analytical skills with exceptional attention to detail.

• Excellent oral and written communication skills, with the ability to effectively influence and present to cross-functional stakeholders.

• Proven ability to work collaboratively and lead initiatives within a matrixed team environment.

• Proficiency in Google Workspace Suite.

Preferred Qualifications

• Knowledge of U.S. and Canadian medical device regulations, as well as Canadian regulations pertaining to cosmetics and drugs.

• Demonstrated experience utilizing SAP and other specialized regulatory tracking software.

• Advanced project management skills with a demonstrated ability to manage multiple high-stakes projects simultaneously.

Travel Requirements

• Expected percentage of travel: 0–10%