Free template

Regulatory Affairs Resume Format (Pharma)

Regulatory affairs managers shortlist on the dossiers you have compiled, the agencies and markets you have handled, and the approvals you have helped win. This clean format keeps those details easy to scan.

Example Regulatory Affairs resume

Neha Joshi
Regulatory Affairs Executive
+91 96XXX XXX67neha.joshi@example.comAhmedabad, Gujaratlinkedin.com/in/neha-joshi-example
Professional Summary

Regulatory affairs executive with 4 years in generic formulations, compiling CTD and eCTD dossiers for ROW markets and filing variations and renewals on CDSCO SUGAM. Handled 30+ submissions and deficiency responses with on-time approvals.

Regulatory Experience
Regulatory Affairs Executive
Aug 2022 – Present
Generic pharma company (example), Ahmedabad
  • Compiled and submitted 30+ CTD / eCTD dossiers for ASEAN, GCC and African markets
  • Responded to 20+ agency deficiency letters within deadline
  • Filed variations and renewals through CDSCO SUGAM
Regulatory Affairs Trainee
Jul 2021 – Jul 2022
Formulation company (example), Vadodara
  • Reviewed labels and artwork for 50+ SKUs
Regulatory Skills & Tools

CTD / eCTD dossiers · Module 1, 2 & 3 compilation · CDSCO submissions · SUGAM portal · Deficiency / query responses · ICH guidelines · Labelling & artwork review

Education
M.Pharm (Regulatory Affairs)
2019 – 2021
College of Pharmacy (example), Ahmedabad
Certifications
eCTD publishing training — Training provider (example), 2023
Languages

English · Hindi · Gujarati

The person and numbers in this example are made up. Your own resume can use any of the four designs and seven colours.

What to include, in this order

  1. 1Name, job title and contact details
  2. 2Professional Summary
  3. 3Regulatory Experience
  4. 4Regulatory Skills & Tools
  5. 5Education
  6. 6Certifications
  7. 7Training & Projects
  8. 8Awards & Achievements

Tips from healthcare hiring

  • Name the dossier types (CTD, eCTD, ACTD) and modules you have worked on.
  • List the markets and agencies: CDSCO, US FDA, EMA, GCC, ASEAN, Africa.
  • Give numbers: dossiers submitted, approvals, query responses.
  • Mention publishing tools and regulatory databases you have used.

Example summary

Regulatory affairs executive with 4 years in generic formulations, compiling CTD and eCTD dossiers for ROW markets and filing variations and renewals on CDSCO SUGAM. Handled 30+ submissions and deficiency responses with on-time approvals.

Regulatory Affairs resume format for freshers

No work experience yet? Keep your resume to one page and let your degree and training carry it:

  1. Contact details and the job title you are applying for
  2. A two or three line summary of what you trained in
  3. Education, with your score
  4. Training & Projects: where, how long, what you did
  5. Skills you can actually do, then certifications

A fresher summary you can adapt:

M.Pharm (Regulatory Affairs) graduate trained in CTD structure, ICH guidelines and CDSCO procedures. Looking for a trainee regulatory affairs role.

Example points for your experience

  • Compiled and submitted 30+ CTD / eCTD dossiers for ASEAN, GCC and African markets
  • Prepared Module 3 CMC sections and responded to 20+ agency deficiency letters within deadline
  • Filed new applications, variations and renewals through the CDSCO SUGAM portal
  • Reviewed labels and artwork against approved product information for 50+ SKUs

Skills to consider

CTD / eCTD dossiersModule 1, 2 & 3 compilationCMC documentationCDSCO submissionsSUGAM portalVariations & renewalsDeficiency / query responsesRegulatory intelligenceICH guidelinesGMP & GDPLabelling & artwork revieweCTD publishing toolsROW markets (ASEAN, GCC, LATAM, Africa)US FDA / EU submissions

Only list the ones you can actually do. In the builder, click a skill to add it.

All of this is built into the editor

Suggestions, a strength score and a job match check, then download your PDF free with a Jobslly account.

Build my Regulatory Affairs resume

Questions about the Regulatory Affairs resume format

What should a regulatory affairs resume include?+

Dossier types and modules you have compiled, agencies and markets handled, number of submissions and approvals, query responses, tools, and your pharmacy degree or RA qualification.

Can a B.Pharm fresher get into regulatory affairs?+

Yes. Highlight knowledge of CTD structure, ICH guidelines and CDSCO procedures, any RA course or project, and attention to detail in documentation.

Ready to apply? See the latest Regulatory Affairs jobs on Jobslly.

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