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Regulatory Project Manager Jobs in Boston, MA (NOW HIRING)

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 ...

Merck Group

Regional Regulatory Manager

Billerica, MA · On-site

Partner with Regulatory Project Management and Submission Management. * May act as direct contact to a local HA (e.g. FDA). Lead the direct interactions with the respective local HA in this case.

Kids for the Future

Project Manager

Waltham, MA · On-site

$94 - $125/hr

The Project Manager is responsible for leading and delivering strategic, operational, digital, regulatory, and merger-related initiatives across the Bank. Working closely with business leaders ...

New

Cambridge Savings Bank

Project Manager

Waltham, MA · On-site

$93K - $125K/yr

The Project Manager is responsible for leading and delivering strategic, operational, digital, regulatory, and merger-related initiatives across the Bank. Working closely with business leaders ...

Zero RFI

Project Manager

Boston, MA · On-site

$115 - $145/hr

About the Job Project Manager Boston - Hybrid We are seeking a Project Manager to serve as an on ... Familiarity with local regulatory approval processes and jurisdictional requirements. * Owner ...

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All JobsRegulatory Project JobsRegulatory Project Manager JobsRegulatory Project Manager Jobs in Boston, MA

Regulatory Project Manager information

See Boston, MA salary details

$41.8K

$111.6K

$176K

How much do regulatory project manager jobs pay per year?

As of Sep 2, 2026, the average yearly pay for regulatory project manager in Boston, MA is $111,554.00, according to ZipRecruiter salary data. Most workers in this role earn between $85,300.00 and $133,600.00 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.

What are popular job titles related to Regulatory Project Manager jobs in Boston, MA?

For Regulatory Project Manager jobs in Boston, MA, the most frequently searched job titles are:

What job categories do people searching Regulatory Project Manager jobs in Boston, MA look for?

The top searched job categories for Regulatory Project Manager jobs in Boston, MA are:

What cities near Boston, MA are hiring for Regulatory Project Manager jobs?

Cities near Boston, MA with the most Regulatory Project Manager job openings:

Regulatory Project Manager jobs near you
Infographic showing various Regulatory Project Manager job openings in Boston, MA as of August 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $111,554 per year, or $53.6 per hour.

NDA Regulatory Strategy Consultant (Remote)

The FDA Group

Boston, MA • Remote

Full-time

Posted 11 days ago

Job description

NDA Regulatory Strategy Consultant

Location: Fully Remote
Work Arrangement: Remote
Start: Late Q4 2026 / Early Q1 2027
Schedule: Approximately 20 hours per week

Position Overview

We are seeking an experienced NDA Regulatory Strategy Consultant to provide senior-level strategic support during the final stages of New Drug Application (NDA) preparation for a life sciences organization.

The consultant will serve as a key regulatory advisor, providing overall strategic oversight of the NDA dossier and helping ensure the submission is complete, consistent, and positioned for FDA readiness. This individual will work closely with the existing regulatory project manager, regulatory writers, and internal stakeholders to review submission content, identify gaps and compliance risks, and maintain consistent regulatory messaging across the dossier.

This is a strategic but hands-on role requiring substantial direct NDA submission experience and the ability to operate independently with minimal guidance. The consultant may also serve as an interim senior regulatory lead while the organization recruits a permanent employee.

Key Responsibilities

  • Provide senior-level strategic oversight of the NDA dossier during final preparation.
  • Guide overall regulatory strategy and help ensure consistent messaging across the submission.
  • Review NDA content for completeness, consistency, compliance risks, and FDA readiness.
  • Identify regulatory gaps and recommend appropriate actions to address issues prior to submission.
  • Work closely with the regulatory project manager, writers, and internal team to maintain alignment across submission activities.
  • Provide practical regulatory guidance and decision support throughout the final stages of NDA preparation.
  • Apply hands-on NDA submission experience to anticipate potential FDA concerns and strengthen submission readiness.
  • Operate independently as a senior regulatory advisor with minimal oversight.
  • Potentially serve as an interim senior regulatory lead until a permanent regulatory employee is hired.

Required Qualifications

  • Significant hands-on experience preparing and supporting NDA submissions.
  • Strong knowledge of FDA regulatory expectations applicable to NDA preparation and submission.
  • Demonstrated ability to provide strategic oversight of complex regulatory dossiers.
  • Experience reviewing submission content, identifying regulatory gaps and compliance risks, and supporting FDA readiness.
  • Ability to collaborate effectively with regulatory project management, writing, and cross-functional internal teams.
  • Ability to operate independently and provide senior-level regulatory guidance with minimal direction.

Ideal Candidate

The ideal consultant is a seasoned regulatory professional with substantial hands-on NDA submission experience who can quickly step into a senior advisory role. This individual will combine strategic regulatory judgment with detailed dossier review capabilities and be comfortable serving as a trusted regulatory lead during a critical stage of submission preparation.