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Regulatory Operations Associate Jobs (NOW HIRING)

Telix Pharmaceuticals (AMER)

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See Yourself at Telix The Associate Director, Regulatory Affairs Operations leads the end-to-end execution of regulatory operational activities, ensuring the efficient, compliant, and timely delivery ...

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Regulatory Operations Associate information

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How much do regulatory operations associate jobs pay per hour?

As of Jul 12, 2026, the average hourly pay for regulatory operations associate in the United States is $26.24, according to ZipRecruiter salary data. Most workers in this role earn between $17.79 and $30.29 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 are Regulatory Operations Associates?

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.

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Regulatory Operations Associate jobs near you

Regulatory Operations Associate

TRI Challenge Convention

Bethesda, MD • Hybrid

Full-time

Posted 20 hours ago

Job description

Prepare standard documentation supporting regulatory filings and distribution to stakeholders. Utilize and maintain hard copy and electronic filing systems for auditable regulatory documents. Maintain effective high-profile communications and interactions with colleagues, collaborators, and clients as appropriate.

Draft, edit, and distribute various documents as needed based on templates and work instructions. Develop and maintain work process tools to promote efficiency and productivity. These may include templates, SOPs, work instructions, checklists, etc.

Track regulatory activity, maintain, and update databases, and ensure that records are complete and current. Provide other administrative regulatory support as needed.Excellent oral and written communication skills; detail-oriented and able to multi-task/prioritize well. Superior organizational skills and customer service abilities are required

Experience publishing regulatory submissions using electronic submission software and proficiency in preparing documents that are compliant with electronic submission standards is preferred. Proficiency in MS Office (Word, Excel, and Outlook); experience with SharePoint is a plus. Must be able to exercise initiative and sound judgment, and to prioritize ongoing projects.

Familiarity with Good Clinical Practices and/or experience of working in an FDA-regulated environment is desirable. General knowledge of the drug and vaccine development process or clinical trials is a plus. This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.Excellent oral and written communication skills; detail-oriented and able to multi-task/prioritize well

Superior organizational skills and customer service abilities are required. Experience publishing regulatory submissions using electronic submission software and proficiency in preparing documents that are compliant with electronic submission standards is preferred. Proficiency in MS Office (Word, Excel, and Outlook); experience with SharePoint is a plus.

Must be able to exercise initiative and sound judgment, and to prioritize ongoing projects. Familiarity with Good Clinical Practices and/or experience of working in an FDA-regulated environment is desirable. General knowledge of the drug and vaccine development process or clinical trials is a plus.

This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.

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