Regulatory affairs specialist resume: example bullets and ATS keywords

Keywords to include where true

Regulatory submissions, marketing authorisation application (MAA), variations, renewals, clinical trial application (CTA), IND/NDA, eCTD, CTD modules, MHRA, EMA, FDA, labelling, SmPC and PIL, regulatory intelligence, regulatory strategy, change control, lifecycle management, medical devices (MDR, UKCA/CE marking, technical files), GxP, Veeva Vault RIM.

Example bullets

• Prepared and submitted [X] variations to the MHRA and EMA in eCTD format.
• Compiled CTD Module 3 sections with the CMC team for a new marketing authorisation.
• Managed SmPC and PIL updates following safety signals, coordinating with pharmacovigilance.
• Assessed change controls for regulatory impact and agreed filing routes.
• Maintained regulatory intelligence summaries on upcoming guidance for the product team.

Coming from clinical research or pharmacy

Clinical research coordinators and pharmacists often move into regulatory roles. Highlight document control, GCP knowledge, protocol amendments, or labelling and product knowledge, using regulatory wording where it's accurate.

ATS tips

• Name agencies and submission types explicitly; recruiters search for them.
• State the product area in your headline, for example "Regulatory Affairs Specialist, Medical Devices".
• Write abbreviations in full once.
• Keep tables out of your submission history; use bullets instead.

Before you apply

Read the advert twice: once for the duties and once for the exact words it uses. Where your experience matches, use the same wording in your summary and bullets, so both the ATS and the recruiter can see the fit at a glance. Leave out anything you can't talk through confidently at interview.