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Regulatory Project Manager Jobs (NOW HIRING)

The position reports to the Regulatory Manager and occasionally works with program technical staff ... Three years of business experience, including project management and fiscal tracking experience

... Regulatory project experience Qualifications Other: PMP or other Project Management certification(s) preferred (also prefer that they be current) Experience with banking / financial services is a ...

... Regulatory project experience. Other: PMP or other Project Management certification(s) preferred (also prefer that they be current) Experience with banking / financial services is a nice-to-have ...

BI Project Manager

San Ramon, CA

$110.10K - $130.20K/yr

... Regulatory project experience Qualifications BI Project Manager, SDLC, waterfall methodology Additional Information Multiple Openings

$90.59K - $111.16K/yr

The Project Manager, Regulatory Implementation is responsible for creating and executing project artifacts including project plans, communication plans, resource plans, and other tools used to guide ...

Required Skills: * 5+ years of Project Management experience * Strong communication and stakeholder ... Experience with digital transformation or regulatory projects

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Regulatory Project Manager information

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$38.5K

$102.7K

$162K

How much do regulatory project manager jobs pay per year?

As of May 29, 2026, the average yearly pay for regulatory project manager in the United States is $102,682.00, according to ZipRecruiter salary data. Most workers in this role earn between $78,500.00 and $123,000.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Regulatory Project Manager, and why are they important?

To thrive as a Regulatory Project Manager, you need a solid understanding of regulatory affairs, project management principles, and often a relevant degree in life sciences or a related field. Familiarity with project management software, regulatory submission platforms, and certifications such as PMP or RAC are highly valued. Strong organizational, leadership, and communication skills set top performers apart in this role. These competencies are crucial for ensuring regulatory compliance, timely project delivery, and effective coordination between cross-functional teams.

How does a Regulatory Project Manager typically coordinate with cross-functional teams during a product submission process?

A Regulatory Project Manager plays a central role in coordinating cross-functional teams, such as R&D, clinical, quality assurance, and manufacturing, during product submission. They facilitate regular meetings, ensure all stakeholders are aligned on timelines and regulatory requirements, and manage documentation flow to meet submission deadlines. Effective communication and proactive issue resolution are key to successfully navigating the complex regulatory landscape and ensuring projects stay on track. This collaborative approach not only streamlines the submission process but also helps anticipate and mitigate potential regulatory challenges.

What is a Regulatory Project Manager?

A Regulatory Project Manager is a professional responsible for overseeing and coordinating regulatory submissions and compliance activities within industries such as pharmaceuticals, biotechnology, or medical devices. They ensure that products meet all regulatory requirements throughout the development and approval process, working closely with cross-functional teams to prepare documentation for submission to regulatory agencies like the FDA or EMA. Their role involves project planning, timeline management, risk assessment, and communication with regulatory authorities to facilitate timely product approvals.

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

AspectRegulatory Project ManagerRegulatory Affairs Specialist
CredentialsTypically requires a degree in life sciences, engineering, or related field; certifications like RAC are commonSimilar credentials; often holds a degree in life sciences and RAC certification
Work EnvironmentManages projects across teams, coordinates regulatory submissions, and ensures compliance timelinesFocuses on preparing regulatory documents, liaising with authorities, and maintaining compliance documentation
Employer & Industry UsageUsed in pharmaceutical, biotech, and medical device companies for project oversightCommon in regulatory departments within similar industries for document preparation and submission

While both roles require regulatory knowledge and similar credentials, the Regulatory Project Manager primarily oversees regulatory projects and timelines, whereas the Regulatory Affairs Specialist concentrates on preparing and managing regulatory submissions and documentation.

More about Regulatory Project Manager jobs
What cities are hiring for Regulatory Project Manager jobs? Cities with the most Regulatory Project Manager job openings:
What states have the most Regulatory Project Manager jobs? States with the most job openings for Regulatory Project Manager jobs include:
Infographic showing various Regulatory Project Manager job openings in the United States as of May 2026, with employment types broken down into 1% Internship, 1% As Needed, 89% Full Time, 6% Part Time, 1% Temporary, and 2% Contract. Highlights an 89% Physical, 1% Hybrid, and 10% Remote job distribution, with an average salary of $102,682 per year, or $49.4 per hour.
Associate Director, Global Regulatory Affairs Project Management

Associate Director, Global Regulatory Affairs Project Management

Revolution Medicines

Redwood City, CA โ€ข Hybrid

Other

Posted 4 days ago


Job description

The Opportunity:

The Associate Director, Global Regulatory Affairs Project Management is an integral part of the global Regulatory Affairs organization and is responsible for translating global regulatory strategies into actionable execution plans.ย  This role applies advanced project management expertise and operational leadership to guide cross-functional teams, supporting planned and ongoing drug marketing applications across RevMed programs.ย  The role partners closely with Global Regulatory Science and Global Filing and Registration and contributes to the broader Global Regulatory Affairs function at RevMed.ย  This position reports to the Senior Director, Global Regulatory Affairs Project Management.

The ideal candidate will have an in-depth understanding of oncology drug development and demonstrated hands-on regulatory project management experience supporting early- and late-stage registrational programs, including the execution of global new drug marketing applications, in alignment with corporate objectives.ย 

Core Responsibilities:

  • Project manages regulatory submissions from initiation through submission, supporting the definition of scope, timelines, prioritization, resource needs, and key deliverables.

  • Develop, maintain, and track comprehensive submission timelines for INDs / CTAs, NDAs / MAAs, amendments, agency interactions, and other key global regulatory activities.

  • Partner with Global and Regional Regulatory Science Leads to advance global regulatory strategies for assigned molecules across indications.

  • Facilitate Global Regulatory Teams and meetings to ensure coordinated development and execution of high-quality, timely global regulatory deliverables at the study level

  • Partner with Global Filing Leads on planning, resourcing, and execution of new drug marketing applications for global agency submissions, interactions, and approvals.

  • Drive the operational planning, coordination, and tracking of new drug marketing application submission activities across cross-functional Filing Teams (including Regulatory, Medical Writing, Nonclinical, Clinical, Safety, Biostatistics, CMC / Pharmaceutical Development and Manufacturing, etc. and external consultants), supporting the Global Filing Lead's strategic vision.

  • Coordinate with global partners to maintain consistent regulatory program plans, ensuring alignment, compliance, and continuity across regions.

  • Proactively identify operational risks, gaps, and bottlenecks; propose and implement solutions, including process improvements and outsourcing strategies, as appropriate.

  • Build and maintain submission dashboards; communicate status, risks, and mitigation strategies to senior management and key stakeholders.

  • Support the development, implementation, and continuous improvement of global regulatory project management processes, templates, tools, dashboards, analytics, and best practices.

  • Champion innovation and operational excellence, identifying opportunities to streamline regulatory project management and enhance submission preparation efficiency and scalability.

Required Skills, Experience and Education:

  • Bachelor's degree in life sciences or related discipline; advanced degree preferred.

  • 12+ years of pharma / biotech industry experience, including 6-8+ years of regulatory project management experience. Hands-on U.S. drug marketing application experience required.

  • Strong working knowledge of global regulatory regulations, guidelines, and submission pathways; familiarity with nonclinical, clinical, and CMC (bio)pharmaceutical development.

  • In-depth knowledge of CTD structure and dossier component management, including coordination across cross-functional filing team contributors and senior leadership.

  • Exceptional project management skills with proven ability to manage multiple complex programs under compressed timelines in a fast-paced, cross-functional environment that values both speed and quality.

  • Excellent communication and interpersonal skills, with demonstrated ability to influence, manage group dynamics, and balance functional, team, and leadership objectives.

  • Ability to think both strategically and tactically and present recommendations to senior leadership and key stakeholders.

  • High proficiency with project management tools including Smartsheet and Microsoft Project, and familiarity with WBS management, timeline development, and critical path analysis; experience with OnePager, Office Timeline, and Veeva RIM is a plus.

Preferred Skills:

  • Experience supporting global regulatory filings including Japan, Canada, and EU / UK submissions.

  • Oncology drug development experience.

  • Experience with complex oncology clinical trial designs (e.g., combination studies, multi-cohort expansions, basket or umbrella master protocols).ย 

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