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Regulatory Affairs Project Manager Jobs (NOW HIRING)

DEKA

Regulatory Affairs Project Manager

Manchester, NH · On-site

DEKA Research & Development has an immediate opening for a Regulatory Affairs Project Manager to contribute to a dynamic, medical device research and development environment. The individual in this ...

Doist

Manager, Regulatory Affairs

Pleasanton, CA · On-site

$150 - $180/hr

The Manager, Regulatory Affairs will work closely with Clinical Affairs, Quality, Engineering ... Serve as the Regulatory Affairs project lead for FDA and international regulatory submissions ...

New

JenaValve

Project Manager, Regulatory Affairs

Irvine, CA · On-site

$130K - $140K/yr

Project Manager, Regulatory Affairs Supervisor/Manager Title: Senior Manager, Regulatory Affairs Job Location & Environment: Remote Summary: Responsible for timely preparation and submission of ...

F. Hoffmann-La Roche AG

$104 - $161/hr

At Global Regulatory Affairs, we strive to be the world's best Regulatory organization, championing ... yourself Project management expertise in an agile environment Excellent knowledge of English.

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How much do regulatory affairs project manager jobs pay per hour?

As of Aug 21, 2026, the average hourly pay for regulatory affairs project manager in the United States is $56.97, according to ZipRecruiter salary data. Most workers in this role earn between $42.07 and $66.59 per hour, depending on experience, location, and employer.

What is a regulatory affairs project manager?

A Regulatory Affairs Project Manager is a professional who oversees and coordinates regulatory processes related to product development, approval, and compliance within industries such as pharmaceuticals, biotechnology, or medical devices. They ensure that products meet all required regulatory standards and are submitted to governmental agencies for approval on time. Their role involves managing timelines, collaborating with cross-functional teams, and staying up-to-date with changing regulations to minimize risks and facilitate product launches.

How does a regulatory affairs project manager typically collaborate with cross-functional teams during product development?

As a Regulatory Affairs Project Manager, you will regularly work with cross-functional teams such as R&D, quality assurance, clinical, and marketing to ensure that projects meet regulatory requirements at every stage. Your role involves coordinating timelines, communicating regulatory expectations, and integrating feedback to guide product development toward successful submissions. Effective collaboration is key, as you'll often lead meetings, resolve regulatory challenges, and provide expert advice to align the team's efforts with evolving global regulations.

What are the key skills and qualifications needed to thrive as a regulatory affairs project manager, and why are they important?

To thrive as a Regulatory Affairs Project Manager, you need a solid understanding of regulatory guidelines, project management principles, and a relevant science or engineering degree. Familiarity with regulatory submission systems (such as eCTD), project management tools (like MS Project), and certifications such as RAC are highly valued. Exceptional organizational, communication, and problem-solving abilities set top performers apart in this field. These skills ensure timely regulatory approvals, compliance with global standards, and effective coordination across cross-functional teams.

What is the difference between Regulatory Affairs Project Manager vs Regulatory Affairs Specialist?

AspectRegulatory Affairs Project ManagerRegulatory Affairs Specialist
ResponsibilitiesOversees regulatory projects, manages teams, ensures compliance timelinesPrepares documentation, conducts research, supports regulatory submissions
Required CredentialsBachelor's degree, often with project management or regulatory certificationsBachelor's degree, regulatory affairs certifications beneficial
Work EnvironmentCross-functional teams, project-based settings, corporate officesRegulatory departments, laboratories, or manufacturing sites
Industry UsageCommon in pharmaceutical, biotech, medical device companiesWidely used in similar industries for compliance support

The Regulatory Affairs Project Manager focuses on leading regulatory projects, coordinating teams, and ensuring compliance deadlines are met. In contrast, the Regulatory Affairs Specialist handles detailed documentation, research, and supports submissions. Both roles require regulatory knowledge and certifications, but the Project Manager has a broader oversight role, often managing multiple projects simultaneously.

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Regulatory Affairs Project Manager jobs near you
Infographic showing various Regulatory Affairs Project Manager job openings in the United States as of August 2026, with employment types broken down into 88% Full Time, 11% Part Time, and 1% Contract. Highlights an 81% Physical, 2% Hybrid, and 17% Remote job distribution, with an average salary of $118,493 per year, or $57 per hour.

Regulatory Affairs Project Manager

Colgate-Palmolive Company

Piscataway, NJ • On-site

$124K - $174K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 29 days ago

Colgate-Palmolive rating

6.4

Company rating: 6.4 out of 10

Based on 23 frontline employees who took The Breakroom Quiz

Job description

No Relocation Assistance Offered
Job Number #173814 - 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.
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 seven years of experience in regulatory affairs, or a related compliance role within the medical device or pharmaceutical industry, with at least 2 years of project management experience.
  • In-depth technical knowledge of medical device GMP standards, specifically ISO 13485, ISO 14971, and FDA 21 CFR Part 820.
  • 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 - $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 should you require accommodation.
For additional Colgate terms and conditions, please click here.
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About Colgate-Palmolive

Sourced by ZipRecruiter

Colgate-Palmolive is a leading global consumer products company, tightly focused on Oral Care, Personal Care, Home Care and Pet Nutrition. Colgate sells its products in over 200 countries and territories around the world under such internationally recognized brand names as Colgate, Palmolive, elmex, Tom's of Maine, Sorriso, Speed Stick, Lady Speed Stick, Softsoap, Irish Spring, Protex, Sanex, Elta MD, PCA Skin, Ajax, Axion, Fabuloso, Soupline and Suavitel, as well as Hill's Science Diet and Hill's Prescription Diet.

Industry

Manufacturing

Company size

10,000+ Employees

Headquarters location

New York, NY, US

Year founded

1806

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