Sr. Manager, Regulatory Affairs

Colgate • Piscataway, NJ

19h • Onsite

About The Position

The Senior Regulatory Affairs Manager leads regulatory strategy and compliance for Colgate-Palmolive’s Oral Care and Personal Care divisions in the U.S. and Canada. The role supports existing commercialized products and the strategic development and introduction of new products, and provides strategic support for high-priority Home Care projects as business needs require. The position is based in Piscataway, New Jersey, and reports to the Sr. Director Regulatory Affairs North America. Expected travel is 0–10%.

Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or a closely related scientific field.
• At least 10 years of progressive regulatory affairs experience in the consumer goods or pharmaceutical industry.
• Expert-level knowledge of U.S. regulations pertaining to cosmetics and drugs.
• Demonstrated experience managing and developing direct reports, with strong people-management and leadership skills.
• Proven ability to independently prepare, manage, and submit successful regulatory documents.
• Strong analytical skills and exceptional attention to detail.
• Excellent oral and written communication skills, including the ability to influence and present to cross-functional stakeholders.
• Ability to collaborate and lead initiatives in a matrixed team environment.
• Proficiency in Google Workspace Suite.

Nice To Haves

• Knowledge of U.S. and Canadian medical device regulations and Canadian regulations for cosmetics and drugs.
• Experience using SAP and specialized regulatory tracking software.
• Advanced project management skills and ability to manage multiple high-stakes projects simultaneously.

Responsibilities

• Lead and implement regulatory strategies and compliance activities for Oral Care and Personal Care products, including cosmetics, drugs, and medical devices, in accordance with applicable U.S. FDA and Health Canada regulations.
• Oversee and prepare complex FDA submissions, including 510(k)s, NDAs, and ANDAs, and serve as a primary liaison with health authorities.
• Partner with cross-functional stakeholders on new product development and gather information for product and site registrations, notifications, and reporting obligations.
• Monitor and interpret regulatory requirements, policies, and guidelines; assess business impacts and prepare strategic communications for internal stakeholders.
• Monitor federal and state restrictions for Chemicals of High Concern and assess and mitigate impacts on the product portfolio.
• Review and approve change controls and Tech Transfer checklists, assess the scope and impact of changes, and recommend implementation plans.
• Review, update, and author Work Instructions and Standard Operating Procedures to formalize processes, establish best practices, ensure compliance, and clarify cross-functional roles and responsibilities.
• Review product claims against regulatory requirements and provide risk assessments.
• Use AI tools and promote digital adoption to improve operational efficiency and streamline departmental workflows.
• Manage, mentor, and coach direct reports, providing strategic guidance, performance feedback, and development support.

Benefits

• Comprehensive medical, dental, and vision coverage.
• Basic life insurance and disability coverage.
• Paid parental leave.
• 401(k) plan with company matching contributions, subject to eligibility requirements.
• Minimum of 15 vacation/PTO days for salaried employees, prorated based on hire date within the calendar year.
• 13 paid holidays.
• Paid sick leave according to role, location, and applicable local laws.
• Potential eligibility for discretionary bonuses and profit-sharing; long-term incentives may be available for Executive-level roles.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior