Sr. Manager, Regulatory Affairs

No Relocation Assistance Offered

Job Number #177156 - Piscataway, New Jersey, United States

Who We Are

Colgate-Palmolive Company is a global consumer products company operating in over 200 countries specializing in Oral Care, Personal Care, Home Care, Skin Care, and Pet Nutrition. Our products are trusted in more households than any other brand in the world, making us a household name!

Join Colgate-Palmolive, a caring, innovative growth company reimagining a healthier future for people, their pets, and our planet. Guided by our core values—Caring, Inclusive, and Courageous—we foster a culture that inspires our people to achieve common goals. Together, let's build a brighter, healthier future for all.

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%

Compensation and Benefits

Salary Range $139,200.00 - $174,000.00 USD

Pay is determined based on experience, qualifications, and location. Salaried employees may also be eligible for discretionary bonuses, profit-sharing, and long-term incentives for Executive-level roles.

Benefits: Salaried employees enjoy a comprehensive benefits package, including medical, dental, vision, basic life insurance, paid parental leave, disability coverage, and participation in the 401(k) retirement plan with company matching contributions subject to eligibility requirements. Additional benefits include a minimum of 15 vacation/PTO days (hourly employees receive a minimum of 120 hours) and 13 paid holidays (vacation days are prorated based on the employee's hire date within the calendar year). Paid sick leave is adjusted based on role and location in accordance with local laws. Detailed information regarding paid sick leave entitlements will be provided to employees upon hiring and may be subject to adjustments based on changes in legislation or company policies.

Our Commitment to Inclusion

Our journey begins with our people—developing strong talent with diverse backgrounds and perspectives to best serve our consumers around the world and fostering an inclusive environment where everyone feels a true sense of belonging. We are dedicated to ensuring that each individual can be their authentic self, is treated with respect, and is empowered by leadership to contribute meaningfully to our business.

Equal Opportunity Employer

Colgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, veteran status (United States positions), or any other characteristic protected by law.

Reasonable accommodation during the application process is available for persons with disabilities. Please complete this request form (https://docs.google.com/forms/d/e/1FAIpQLSdaxk\_eF4utznQoVHlxmL9jVFJbOkM4Oe5CAdKOg-h9EPdLfg/viewform) should you require accommodation.

For additional Colgate terms and conditions, please click here (https://www.colgatepalmolive.com/content/dam/cp-sites/corporate/corporate/en\_us/corp/locale-assets/pdf/colgate-terms-and-conditions-2023.pdf) .

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