Regulatory Affairs Project Manager

Colgate-Palmolive; Piscataway Township (NJ); Presencial; USD 124.000 - 155.000; Tempo integral

Benefícios oferecidos por esta vaga

Discretionary bonuses

Profit sharing

Long-term incentives

401(k) with company match

Resumo da vaga

Colgate-Palmolive in Piscataway, New Jersey is seeking a Regulatory Affairs Project Manager to lead global regulatory submissions and maintain our QMS. You will drive cross-functional teams to prepare complex filings (510Ks, NDAs, ANDAs, NDS) for FDA and Health Canada, ensuring ISO 13485, 14971, and Part 820 alignment.

This role emphasizes risk management, continuous improvement, and strategic stakeholder reporting, with a strong focus on North America market needs and fast-paced portfolio

Qualificações

• Bachelor’s degree in Quality Management, Life Sciences, Regulatory Affairs, or a related technical field.
• At least 8 years of experience in regulatory affairs or a related compliance role in medical devices or pharma.
• In-depth knowledge of ISO 13485, ISO 14971, and FDA 21 CFR Part 820.
• 2 years of project management experience.
• Proficiency with eQMS, DMS, and PM software such as Smartsheet.
• Proven track record leading cross-functional teams and communicating regulatory information clearly.

Responsabilidades

• Regulatory Submission Leadership: lead cross-functional projects to prepare, review, and deliver submissions (510Ks, NDAs, ANDAs, NDS) to FDA & Health Canada.
• QMS & GMP Compliance: coordinate QMS projects ensuring ISO/FDA requirements are met.
• Risk Management & Lifecycle Monitoring: identify risks and develop mitigation strategies.
• Environmental & Chemical Compliance: manage regulatory data collection for PFAS, TSCA, DSL, etc.
• Stakeholder Reporting & Automation: present updates to senior leadership; automate workflows with IT.
• Continuous Improvement & Training: lead lessons learned and SOP/WI updates; train team members.

Conhecimentos

Cross-functional leadership

Regulatory communication

Project management

Formação

Bachelor’s degree in Quality Management, Life Sciences, Regulatory Affairs, or related technical field

Master’s degree in Quality Management, Life Sciences, or Regulatory Affairs

Ferramentas

Smartsheet

GreenlightGuru eQMS

DMS systems

Descrição da vaga

Relocation Assistance Offered Within Country

Job Number #177157 - 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.

Title: Regulatory Affairs Project Manager

Location: Piscataway, New Jersey

Role Summary

As the Regulatory Affairs Project Manager, you will lead the planning, execution, and oversight of complex global regulatory submissions and ensure the rigorous maintenance of our Medical Device Quality Management System (QMS). This critical leadership role directly supports rapid portfolio growth, focusing on medical device and Rx drug innovation to meet the company’s 2030 objectives. By driving continuous improvement in quality processes and partnering with cross-functional teams, you will safeguard compliance while accelerating commercialization timelines for North America. This position offers an exciting opportunity to spearhead high-impact projects that shape the future of our professional clinical portfolio.

Responsibilities

• Regulatory Submission Leadership: Leads cross-functional projects to prepare, review, and deliver complex regulatory submissions (e.g., 510Ks, NDAs, ANDAs, NDS) to the FDA and Health Canada on time.
• QMS and GMP Compliance: Coordinates critical Quality Management System projects, ensuring all system implementations and process improvements align strictly with ISO 13485, ISO 14971, and FDA 21 CFR Part 820 requirements.
• Risk Management & Lifecycle Monitoring: Proactively identifies and monitors project risks, developing robust mitigation strategies to protect business continuity and minimize timeline impacts or regulatory penalties.
• Environmental & Chemical Compliance: Manages evolving cross-category requirements for complex chemical reporting and environmental compliance data collection, including PFAS, TSCA, DSL, and SmartLabel initiatives.
• Stakeholder Reporting & Automation: Serves as the primary point of contact for project-related inquiries, presenting regular updates to senior leadership and partnering with IT to automate regulatory workflows.
• Continuous Improvement & Training: Heads "lessons learned" sessions and updates documentation standards (SOPs and WIs) while providing targeted training to team members on advanced project management methodologies.

Required Qualifications

• Bachelor’s degree in Quality Management, Life Sciences, Regulatory Affairs, or a related technical field.
• At least 8 years of experience in regulatory affairs, or a related compliance role within the medical device or pharmaceutical industry
• In-depth technical knowledge of medical device GMP standards, specifically ISO 13485, ISO 14971, and FDA 21 CFR Part 820.
• 2 years of project management experience.
• Direct professional proficiency using electronic Quality Management Systems (eQMS), document management systems (DMS), and advanced Project Management software such as Smartsheet.
• Proven track record of leading cross-functional teams and communicating complex technical regulatory info clearly to diverse stakeholders.

Preferred Qualifications

• Master’s degree in Quality Management, Life Sciences, or Regulatory Affairs.
• Professional certification in Quality Management, such as a Certified Medical Device Auditor (CMDA) or Certified Quality Auditor.
• Advanced training or professional certification in Project Management (such as a PMP certification).
• Hands-on familiarity with the GreenlightGuru eQMS system or closely related medical device compliance platforms.

Compensation And Benefits

Salary Range $124,000.00 - $155,000.00 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 should you require accommodation.

For additional Colgate terms and conditions, please click here.