Regulatory Affairs

The role of regulatory affairs

Regulatory affairs teams prepare, organize, and maintain information needed for regulatory submissions and approvals. In clinical research, this includes supporting study applications, tracking amendments, and keeping essential records current.

The work helps research teams understand applicable requirements and coordinate the information needed throughout a study.

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What the work involves

• Preparing and organizing documents for submissions
• Tracking approvals, amendments, and submission deadlines
• Reviewing documents for completeness and consistency
• Maintaining regulatory records and version control
• Coordinating responses to requests from regulatory authorities and ethics committees

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Roles within this pathway

Titles and responsibilities vary by employer.

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• Regulatory Affairs Assistant / Associate: Supports submission preparation, document review, and regulatory tracking.
• Regulatory Affairs Specialist: Coordinates assigned submissions and helps teams address applicable regulatory requirements.
• Clinical Regulatory Coordinator: Maintains site regulatory files and supports ethics submissions, amendments, and continuing review.
• Regulatory Operations Associate: Supports the formatting, publishing, and management of electronic submission documents.

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A pathway for diverse backgrounds

Regulatory affairs draws on knowledge developed across life sciences, healthcare, research administration, and document management. Experience interpreting requirements, reviewing detailed information, and maintaining organized records provides a relevant foundation for supporting regulatory activities.

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Accelerate your path into clinical research

Clintern Ascend combines industry training with a remote internship at a clinical research organization (CRO) partner. Gain experience with research workflows, essential documentation, and study requirements, without taking time off work or school.

Dedicated résumé, interview, and career positioning support helps you communicate your experience to employers and pursue your next step with confidence. Specialized regulatory positions may also require knowledge of particular products, submission systems, or regional requirements.

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