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Regulatory Operations Manager Jobs (NOW HIRING)

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 ...

New

Kalshi Inc

Compliance, Regulatory Operations

New York, NY · On-site

$100K - $150K/yr

... operations regulator-ready as the business scales. You will own a broad set of day-to-day ... Build and manage employee compliance training, certification, and attestation processes across the ...

Centene

Regulatory Operations Analyst III

Experience in commercial health insurance, Medicaid managed care, claims operations, compliance ... Experience supporting regulatory audits, investigations, agency inquiries, corrective action plans ...

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Regulatory Operations Manager information

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$31K

$63.5K

$118.5K

How much do regulatory operations manager jobs pay per year?

As of Aug 22, 2026, the average yearly pay for regulatory operations manager in the United States is $63,456.00, according to ZipRecruiter salary data. Most workers in this role earn between $41,000.00 and $77,500.00 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.
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Regulatory Operations Manager jobs near you
Infographic showing various Regulatory Operations Manager job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 84% Full Time, 11% Part Time, 1% Temporary, 2% Contract, and 1% Nights. Highlights an 94% Physical, 2% Hybrid, and 4% Remote job distribution, with an average salary of $63,456 per year, or $30.5 per hour.

Regulatory Operations Specialist - Temporary

Twist Bioscience

Portland, OR • On-site

Temporary

Posted 24 days ago

Twist Bioscience rating

7.7

Company rating: 7.7 out of 10

Based on 7 frontline employees who took The Breakroom Quiz

Job description

The Regulatory Operations Specialist is responsible for ensuring the efficient and compliant management of regulatory documentation, with a primary focus on Safety Data Sheets (SDS), product labeling, and SOP's. This role is crucial in supporting global product compliance, ensuring that all documentation accurately reflects regulatory requirements and product specifications.


What You'll Be Doing
Initiate, author, and maintain Safety Data Sheets (SDS) for all Twist products, ensuring 
compliance with global regulations.
Collaborate with cross-functional teams to obtain necessary product composition data and hazard
information for accurate SDS generation.
Manage the review, approval, and distribution of SDS to internal and external stakeholders.
Carries out duties in compliance with established business policies.
Perform day to day administration activities on EQMS as per approved procedures.
Work closely and collaborate with the Business Process Owner and EQMS users to develop and 
document configuration changes to meet business need
Perform other duties & projects as assigned.
Ability to travel 5%
Follow regulatory and ISO 13485 requirements.


What You'll Bring to the Team
Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Biochemistry) or equivalent 
combination of education and work-related experience.
Minimally 2 years of experience Regulatory Operations within a biotechnology, life sciences, or 
chemical manufacturing company or another Regulated Industry.
Expertise in developing technical documentation, including Safety Data Sheets (SDS), SOP, and 
work instructions
Familiarity with Quality Management Systems and electronic document control systems (eQMS)
Experience with Google Suite and/or MS Office Products required.
Experience with Master Control, Atlassian Confluence and/or JIRA preferred.
Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, 
influential, targeted to audience) required.
Flexible, with ability to work effectively in a fast-paced, dynamic environment with shifting and 
competing demands is required

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