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Regulatory 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 ...

Legend Biotech USA, Inc.

Legend Biotech is seeking a Manager, Regulatory Project Management as part of the Regulatory team based in Somerset, NJ.Role OverviewThis role will be reporting to the Director of Project Management ...

INTELLISWIFT INC

BI Project Manager

San Ramon, CA · On-site

... 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 ...

Jobsbridge

BI Project Manager

San Ramon, CA · On-site

... 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 ...

Tufts Medicine

Regulatory Coordinator

Boston, MA · On-site

Job Profile Summary This role focuses on managing operational aspects of ongoing projects from ... Assists with coordinating aspects of protocol submissions, prepares and submits regulatory ...

Jobsbridge

BI Project Manager

San Ramon, CA · On-site

$110K - $130K/yr

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

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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 Aug 20, 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 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.

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 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.

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.

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What cities are hiring for Regulatory Project Manager jobs?

Cities with the most Regulatory Project Manager job openings:

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Regulatory Project Manager jobs near you
Infographic showing various Regulatory 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 $102,682 per year, or $49.4 per hour.

Sr. Specialist, Regulatory Project Management

West Pharmaceutical Services

Exton, PA • On-site

Full-time

Re-posted 9 days ago

West Pharmaceutical Services rating

8.5

Company rating: 8.5 out of 10

Based on 32 frontline employees who took The Breakroom Quiz

13th of 120 rated packaging manufacturers

Job description

This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week.
Who We Are:
At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?
There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.
We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.
Job Summary
  • The Senior Specialist, Regulatory Project Management is responsible for leading regulatory project execution for West's global portfolio of medical devices, combination products, software-enabled devices/SaMDs, and packaging components.
  • This role partners with the Regulatory Affairs Lead, Cross-functional SMEs, and external stakeholders to drive regulatory deliverables across development, submission, approval, and post-market lifecycle phases.
  • The successful candidate will bring a strong combination of medical device technical understanding, knowledge of global regulatory frameworks, and project management capability to support timely, compliant regulatory submissions and lifecycle activities.
  • The role supports FDA premarket submissions (510(k)), EU MDR Technical Documentation, Master Files (DMF/MAF), change notifications, information request responses, post-approval commitments, and post-market regulatory deliverables.

Essential Duties and Responsibilities
  • As Regulatory Project Management, lead execution for assigned medical device, combination product, SaMD/software-enabled device, and packaging component programs across the product lifecycle.
  • Develop and manage integrated regulatory project plans, timelines, dashboards, risk/issue logs, decision trackers, and escalation pathways to support timely execution of deliverables.
  • Monitor project milestones, dependencies, resource needs, and risks; proactively escalate issues to leadership with recommended mitigation actions.
  • Coordinate the preparation, review, approval, and submission of global regulatory filings, information request responses, change notifications, and post-market regulatory reports.
  • Partner with Regulatory Affairs Leads and cross-functional subject matter experts to align regulatory strategy, technical deliverables, submission readiness, and lifecycle planning.
  • Apply working knowledge of medical device design controls, risk management, verification and validation, usability/human factors, software documentation where applicable, labeling, and post-market requirements to identify technical or regulatory gaps.
  • Support interactions with health authorities, notified bodies, pharmaceutical partners, and other external stakeholders by coordinating documentation, responses, commitments, and follow-up actions.
  • Contribute to the continuous improvement of Regulatory Project Management tools, templates, procedures, metrics, and best practices.

Education & Experience
  • Education: Bachelor's degree in engineering, science, regulatory affairs, or a related technical discipline required; advanced degree preferred or equivalent experience
  • Experience: Bachelor's degree with 5 years, or advanced degree with minimum 2 years relevant experience in medical device or combination product environments

Knowledge, Skills and Abilities
  • Experience supporting medical device development and/or regulatory activities across development, registration, and lifecycle management phases.
  • Working knowledge of applicable regulatory and quality frameworks, including FDA quality management system requirements (QSR/QMSR), EU MDR, ISO 13485, and other relevant global standards and guidance documents.
  • Demonstrated project management capability, including development and maintenance of integrated timelines, milestone tracking, risk and issue management, stakeholder communication, meeting facilitation, and escalation management.
  • Strong written and verbal communication skills, with the ability to distill complex technical, regulatory, and quality information for cross-functional teams and leadership.
  • Ability to work independently, manage competing priorities, and influence cross-functional stakeholders in a fast-paced, matrixed environment.
  • Experience supporting successful FDA, EU MDR, or other global regulatory submissions and interactions with health authorities or notified bodies.
  • Experience with Class II and/or Class III medical devices, combination products, drug delivery systems, SaMD/software-enabled devices, or packaging components used with pharmaceutical or biologic products.
  • Familiarity with combination product requirements, device constituent part expectations, 21 CFR Part 4, software lifecycle documentation, cybersecurity, and usability/human factors requirements.
  • Working knowledge of design control principles, including technical documentation, risk management (ISO 14971), verification and validation, change control, and product lifecycle management.
  • Experience with medical device lifecycle activities, including change controls, complaints, CAPAs, post-market surveillance, technical documentation updates, and regulatory impact assessments.
  • Experience working with pharmaceutical partners, contract manufacturers, notified bodies, health authorities, or other external regulatory stakeholders.
  • Regulatory Affairs Certification, Project Management Professional certification, or equivalent certification preferred.

Travel Requirements
5%: Up to 13 business days per year
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
Additional Requirements
  • Ability to work independently in a fast-paced, dynamic environment with requirement to adhere to multiple time-sensitive commitments.
  • Ability to comprehend principles of math, science, engineering, and medical device use.
  • Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality.
  • Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents.
  • Ability to review, collate, describe, and summarize scientific and technical data.
  • Ability to organize complex information and combine pieces of information to form general rules or conclusions.
  • Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one.
  • Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments.
  • Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams.
  • Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above.
  • Ability to write and record data and information as required by procedures
  • Proficiency in the use of personal computers and computer programs, particularly, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company).

#LI-DJ1 #LI-HYBRID
West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening.

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