Regulatory Affairs Specialist: what the role actually involves
A Regulatory Affairs Specialist prepares, compiles and manages the regulatory submissions and correspondence that keep a clinical trial or product moving through agency review, and keeps regulatory documentation current and audit-ready.
This role sits in the regulatory affairs pathway.
What this role involves
- Compiling and formatting regulatory submissions, such as INDs, CTAs or amendments
- Tracking submission timelines against agency review clocks
- Drafting and reviewing correspondence with regulatory agencies
- Maintaining regulatory document repositories for currency and completeness
- Reviewing labeling, protocol and informed consent documents for regulatory compliance
- Coordinating input from clinical, safety, quality and medical writing functions for a submission
Where this role sits in drug development
Regulatory Affairs works across the full lifecycle, from the initial application to conduct a trial through to submissions supporting approval, keeping the regulatory record accurate at every stage.
BORAKA pathways for this role
- Explore BORAKA Academy
Role-mapped learning for regulatory documentation and submissions.
Go - See how assessment works
Submission and review casebooks scored against a rubric.
Go - Get a role readiness report
A structured look at readiness against regulatory affairs work.
Go - Explore Careers
Career strategy for professionals targeting regulatory roles.
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Frequently asked questions
What is the difference between regulatory affairs and clinical operations?
Clinical operations runs the day-to-day conduct of a trial. Regulatory affairs manages the submissions, correspondence and documentation that keep that trial, and eventually the product, in compliance with agency requirements.
What is an IND or CTA?
An Investigational New Drug (IND) application and a Clinical Trial Application (CTA) are examples of the regulatory filings required before a clinical trial can begin in a given jurisdiction. The exact filing type and process depend on the country and the development stage.
Do I need a scientific degree for regulatory affairs?
Many regulatory professionals have a scientific or health-sciences background, and requirements vary by employer and by the complexity of the submissions involved. Each employer sets its own requirements.
How does regulatory affairs work relate to labeling and consent documents?
Regulatory specialists commonly review protocol, labeling and informed consent language to confirm it meets applicable regulatory and agency-specific requirements before it is used or submitted.
What does career progression in regulatory affairs typically look like?
Progression often moves from documentation and submission support toward strategic regulatory roles that plan a product's overall regulatory pathway, and can also lead toward Quality functions. The specific path depends on the person and employer.