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Regulatory Operations Associate Jobs in Massachusetts

Partners Capital

Communications Operations Associate

Boston, MA · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Position Description The Communications Operations Associate is the operational backbone of our ... Ensure full compliance with all local data protection regulations and privacy controls, and any ...

Aequor

Vivarium Operations Associate I Location: Cambridge, MA (Onsite) Pay Rate: ***/Hour - ***/Hour ... Often responsible for ensuring compliance with all institutional and regulatory protocols, policies ...

Lancesoft

Vivarium Operations Associate I

Cambridge, MA · On-site

$21.42 - $25/hr

Vivarium Operations Associate I Location: Cambridge, MA (Onsite) Pay Rate: /Hour - /Hour (Lowest ... Often responsible for ensuring compliance with all institutional and regulatory protocols, policies ...

Partners Capital

Business Operations Associate

Boston, MA · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Position Description The Business Operations Associate will serve as a cornerstone of the Boston ... Ensure full compliance with all local data protection regulations and privacy controls, and any ...

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All JobsRegulatory Operations Associate JobsRegulatory Operations Associate Jobs in Massachusetts

Regulatory Operations Associate information

See Massachusetts salary details

$12

$28

$58

How much do regulatory operations associate jobs pay per hour?

As of Aug 14, 2026, the average hourly pay for regulatory operations associate in Massachusetts is $28.66, according to ZipRecruiter salary data. Most workers in this role earn between $19.42 and $33.08 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a regulatory operations associate, and why are they important?

To excel as a Regulatory Operations Associate, you generally need a background in life sciences or a related field, strong attention to detail, and experience with regulatory documentation processes. Familiarity with electronic document management systems (EDMS), eCTD publishing tools, and knowledge of regulatory submission standards are typically required. Excellent organizational skills, communication, and the ability to manage multiple deadlines help candidates stand out. These competencies ensure accurate, timely regulatory submissions and compliance, which are critical for product approvals and organizational success.

What is a regulatory operations associate?

Regulatory Operations Associates are professionals who support the preparation, submission, and management of documents required by regulatory agencies for product approvals, especially in industries like pharmaceuticals, biotechnology, and medical devices. They ensure that submissions comply with legal and regulatory standards, track submission timelines, and often use specialized software for document management. Their work is crucial for maintaining compliance and facilitating smooth communication between their company and regulatory authorities. Additionally, Regulatory Operations Associates may coordinate with cross-functional teams to gather necessary documentation and maintain up-to-date records.

How does a regulatory operations associate typically collaborate with cross-functional teams within an organization?

Regulatory Operations Associates frequently work alongside regulatory affairs, quality assurance, clinical, and legal teams to ensure that all submissions and documentation comply with industry standards and governmental regulations. They coordinate the collection, formatting, and timely submission of regulatory documents, often acting as a liaison between departments to resolve any discrepancies or gather necessary information. Effective communication and organization are key, as the role requires balancing multiple deadlines and adapting to evolving requirements set by regulatory authorities.

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

AspectRegulatory Operations AssociateRegulatory Affairs Specialist
Required CredentialsBachelor's degree, familiarity with regulatory processesBachelor's degree, often with certifications in regulatory affairs
Work EnvironmentSupportive regulatory teams, administrative tasksStrategic planning, compliance management
Employer & Industry UsagePharmaceutical, biotech, healthcare companiesPharmaceutical, medical device, biotech sectors
Common Search & ComparisonYesNo

The Regulatory Operations Associate typically handles administrative and operational support within regulatory teams, focusing on document management and submission processes. In contrast, the Regulatory Affairs Specialist is more involved in strategic compliance, ensuring products meet regulatory standards. Both roles are essential in regulated industries like pharma and biotech, but they differ in scope and responsibilities.

What are the most commonly searched types of Regulatory Operations jobs in Massachusetts?

The most popular types of Regulatory Operations jobs in Massachusetts are:

What are popular job titles related to Regulatory Operations Associate jobs in Massachusetts?

For Regulatory Operations Associate jobs in Massachusetts, the most frequently searched job titles are:

What job categories do people searching Regulatory Operations Associate jobs in Massachusetts look for?

The top searched job categories for Regulatory Operations Associate jobs in Massachusetts are:

What cities in Massachusetts are hiring for Regulatory Operations Associate jobs?

Cities in Massachusetts with the most Regulatory Operations Associate job openings:

Regulatory Operations Associate jobs near you
Infographic showing various Regulatory Operations Associate job openings in Massachusetts as of August 2026, with employment types broken down into 87% Full Time, 10% Part Time, 1% Temporary, and 2% Contract. Highlights an 94% Physical, 2% Hybrid, and 4% Remote job distribution, with an average salary of $59,617 per year, or $28.7 per hour.

Associate Director, Regulatory Operations

Rhythm Pharmaceuticals

Boston, MA • On-site

Full-time

This job post has expired 1 day ago. Applications are no longer accepted.

Job description

Company Overview
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.
Opportunity Overview
The Associate Director (AD) of Regulatory Operations is responsible for assisting the Head of Regulatory Operations in maintaining Rhythm’s regulatory submission standards and current electronic submission guidelines/requirements. This role involves managing the preparation of eCTD submission-ready documents, coordinating across functions, and ensuring quality, accuracy, and adherence to regulatory guidelines. Additionally, the Associate Director supports the preparation and submission of Investigational New Drug applications (INDs), New Drug applications (NDAs), annual reports, Development Safety Update Reports (DSURs), and safety reports to regulatory authorities.
Responsibilities and Duties
  • Manage regulatory operations activities, ensuring timely and accurate regulatory submissions, and collaborating with cross-functional teams for our US, EU, UK and Health Canada regions
  • Identify/address opportunities to enhance operational effectiveness and drive process improvements within the department
  • Manage regulatory operations activities, including preparation of eCTD submission-ready documents, coordination across functions, and adherence to regulatory guidelines and processes
  • Support development program projects by collaborating with multi-disciplinary project teams to ensure successful program deliverables
  • Assist in the development of Standard Operating Procedures (SOPs) quality assurance, and records management practices related to regulatory operations activities
  • Track regulatory department information such as commitments with health authorities and NDA/IND commitments
  • Act as an expert resource for eCTD submissions to FDA, ensuring compliance with internal and health authority standards
  • Support the development and maintenance of operations resources for submission documents
  • Identify new or revised regulatory policies and initiate activities to support compliance
  • Participate in special projects and process improvement initiatives

Qualifications and Skills
  • Bachelor’s degree in life/physical sciences or related field is preferred 
  • 8+ years of highly relevant pharmaceutical/biotechnology experience in Regulatory Affairs Operations
  • Knowledge and understanding of the drug development process
  • Strong knowledge of FDA and Global EU/UK regulations and guidelines, especially CTD and eCTD structure
  • Experience with Veeva RIM EDMS
  • Highly proficient in Microsoft Office suite
  • Ability to balance both strategic and operational approaches, “think outside the box” and to manage multiple tasks in a fast-paced environment
  • Detail-oriented and highly organized
  • Excellent interpersonal skills and ability to develop collaborative partnerships with key stakeholders
     
This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role may involve some travel.
The expected salary range for this position is $160,000 - $240,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance. This role may be eligible for benefits and other compensation such as restricted stock units.
More about Rhythm
We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause.  Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism.
At Rhythm our core values are:
  • We are committed to advancing scientific understanding to improve patients’ lives
  • We are inspired to tackle tough challenges and have the courage to ask bold questions
  • We are eager to learn and adapt
  • We believe collaboration and ownership are foundational for our success
  • We value the unique contribution each individual brings to furthering our mission

Rhythm is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service, or any other class protected by state or federal law.
Headquartered in Boston, Rhythm is proud to have been named one of the Top Places to Work in Massachusetts.
 

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