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Regulatory Operations Manager Jobs in Boston, MA

TalentCraft

Director, Regulatory Operations

Waltham, MA · On-site

$161K - $213K/yr

Director, Regulatory Affairs Operations The Director of Regulatory Affairs Operations, with level ... The ideal candidate will bring strong project management expertise, extensive experience with eCTD ...

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Regulatory Operations Manager information

See Boston, MA salary details

$33.7K

$68.9K

$128.7K

How much do regulatory operations manager jobs pay per year?

As of Aug 22, 2026, the average yearly pay for regulatory operations manager in Boston, MA is $68,939.00, according to ZipRecruiter salary data. Most workers in this role earn between $44,500.00 and $84,200.00 per year, depending on experience, location, and employer.

What does a regulatory operations manager do?

A Regulatory Operations Manager oversees the processes and systems required to ensure an organization complies with all regulatory requirements, especially in highly regulated industries like pharmaceuticals, finance, or healthcare. Their responsibilities often include managing the submission of documents to regulatory agencies, ensuring accurate record-keeping, developing compliance strategies, and coordinating with various internal departments. They play a critical role in maintaining regulatory standards and facilitating timely approvals for product launches or business activities.

What are the key skills and qualifications needed to thrive as a regulatory operations manager?

To thrive as a Regulatory Operations Manager, you need expertise in regulatory compliance, project management, and a relevant degree in life sciences or a related field. Familiarity with electronic document management systems (EDMS), regulatory submission platforms like eCTD, and knowledge of global regulatory requirements are typically required. Strong attention to detail, organizational skills, and effective cross-functional communication set outstanding professionals apart in this role. These competencies are crucial for ensuring timely, accurate regulatory submissions and facilitating seamless collaboration within regulatory and cross-functional teams.

How does a regulatory operations manager collaborate with cross-functional teams to ensure timely regulatory submissions?

A Regulatory Operations Manager works closely with regulatory affairs, clinical, quality assurance, and project management teams to coordinate the preparation, review, and submission of regulatory documents. They serve as a central point of contact, facilitating communication and aligning timelines to ensure all required materials are gathered and compliant with regulatory standards. By organizing regular meetings and utilizing document management systems, they help streamline the submission process and proactively identify and resolve potential bottlenecks.

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

AspectRegulatory Operations ManagerRegulatory Affairs Specialist
CredentialsTypically requires a bachelor’s degree in life sciences, regulatory affairs, or related field; certifications like RAC are commonSimilar credentials; often holds a bachelor’s degree and may pursue regulatory certifications
Work EnvironmentManages regulatory processes, documentation, and compliance within organizations, often overseeing teamsFocuses on preparing and submitting regulatory documents, ensuring compliance with regulations
Industry UsageUsed across pharmaceutical, biotech, and medical device companies for operational oversightCommonly found in similar industries, focusing on regulatory submissions and communication with authorities

The Regulatory Operations Manager oversees the regulatory process, managing teams and ensuring compliance, while the Regulatory Affairs Specialist concentrates on preparing submissions and liaising with regulatory agencies. Both roles require similar credentials and are vital in regulated industries, but their focus areas differ slightly.

Is regulatory compliance a stressful job?

Regulatory Operations Managers often find regulatory compliance to be demanding due to strict deadlines, detailed documentation, and the need to stay current with evolving regulations. The role requires strong attention to detail, organizational skills, and the ability to manage multiple priorities, which can contribute to work-related stress.

Is regulatory operations a good career path?

Regulatory operations is a viable career path for professionals interested in compliance, documentation, and process management within regulated industries such as pharmaceuticals, biotech, and healthcare. It often requires strong attention to detail, knowledge of regulatory requirements, and proficiency with tools like document management systems. The role offers opportunities for advancement and specialization, with demand driven by industry regulations and compliance needs.

What are the most commonly searched types of Regulatory Operations jobs in Boston, MA?

The most popular types of Regulatory Operations jobs in Boston, MA are:

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

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

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

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

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

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

Regulatory Operations Manager jobs near you
Infographic showing various Regulatory Operations Manager job openings in Boston, MA as of August 2026, with employment types broken down into 1% As Needed, 79% Full Time, 15% Part Time, 3% Temporary, and 2% Contract. Highlights an 93% Physical, 2% Hybrid, and 5% Remote job distribution, with an average salary of $68,935 per year, or $33.1 per hour.

Director, Regulatory Operations

Keros Therapeutics

Lexington, MA • On-site, Remote

$206K - $227K/yr

Full-time

Re-posted 4 days ago

Job description

At Keros, our mission is to deliver significant clinical benefit to a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (TGF-ß) family of proteins. With a focus on developing differentiated product candidates that are designed to alter TGF-β signaling, we aim to target the pathways critical for the growth, repair and maintenance of blood cells and a number of tissues, including bone, skeletal muscle, adipose and heart tissue. We believe our product candidates have the potential to unlock the full therapeutic benefits of modulating the TGF-β superfamily and provide disease-modifying benefit to patients.
Job Summary:
Reporting to the Head Regulatory Affairs, the Director of Regulatory Operations will be responsible for establishing the Regulatory Operations role at Keros. This individual will leverage their extensive knowledge of Regulatory Operations to support Keros' growing regulatory needs including inhouse publishing as well as working with multiple external vendors.
Primary Responsibilities:
  • Oversee all Regulatory Operations deliverables, including management of Health Authority correspondence/submission archives, business administration of the Veeva Vault Regulatory Information Management system, submission management, and training of associated business processes
  • Implement training strategies, develop training materials, and lead training delivery for effective adoption of Vault RIM
  • Manage user groups and workflows and create and maintain archives of Health Authority interactions
  • Develop, manage, and distribute reports, dashboards, and templates to meet user needs
  • Contribute to the writing, review, and implementation of standards and procedures related to regulatory information management
  • Partner with IT and Quality to support system validation activities
  • Maintain proficiency in Vault RIM and maintain current knowledge of regulations, best practices, and guidelines related to RIM
  • Provide eCTD/CTD publishing services including rendering, bookmarking, hyperlinking, compilation, table of contents creation and QC regulatory submissions to Regulatory agencies
  • Coordinate publishing deliverables and act as the primary point of contact for various regulatory functions (Regulatory Affairs, CMC, Labeling, etc.) for major submissions (IND, BLA, etc.)
  • Write or review internal work instructions and standard operating procedures (SOPs) pertaining to submission preparation (electronic or paper)
  • Create, update and maintain submission templates that meet global regulatory requirements

Qualifications:
  • BA/BS or equivalent experience
  • At least 12+ years of industry experience with at least 7+ years experience in regulatory operations
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
  • Prior experience running large scale RA projects within the biotech industry
  • Extensive knowledge of eCTD, e-publishing systems for preparing regulatory submissions as well as regulatory management systems (e.g. Veeva RIM)
  • Experienced in MS Word, Excel, PowerPoint, and Adobe Acrobat, Veeva Vault RIMs
  • Ability to thrive in a collaborative and fast-paced team environment

This pay range represents the base hourly rate or base annual full-time salary for all positions in the job grade within which this position falls. The actual base salary offer will depend on a variety of factors including experience, education, and other relevant factors.
Potential base pay range
$206,000-$227,000 USD
Our Diversity, Equity & Inclusion Mission Statement:Keros is an inclusive company. We believe that diversity drives innovation. We continue to build an inclusive culture that encourages, supports, and celebrates the diverse voices of our employees. As such, Keros takes a holistic approach in mentoring, coaching, and developing all of our Keros team members.
Keros Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.
Recruitment & Staffing Agencies:Keros Therapeutics does not accept unsolicited resumes from any source other than the candidate directly. Any unsolicited submission by an agency to Keros is prohibited. Any resume submitted by an agency without a signed contract or expressed consent by a member of the Keros Therapeutics Human Resources Department, will be considered property of Keros Therapeutics, and no fee shall be owed with respect thereto.

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