| Detail | For this role |
|---|---|
| Department | Pharma |
| Level | Mid level |
| Reports to | Regulatory Affairs Manager |
| Direct reports | None |
| Experience | 1 to 4 years in regulatory affairs |
Regulatory Affairs Officer job description template
Copy this job description, replace the text in square brackets and post it on your careers page or a job portal.
Job title: Regulatory Affairs Officer
Department: Pharma
Reports to: Regulatory Affairs Manager
Location: [City], [office, branch or site]
About the role
A Regulatory Affairs Officer prepares and compiles the documents that get pharmaceutical products approved and keep them compliant. They assemble dossiers, prepare submissions to authorities, track licences and renewals, help answer queries, and maintain regulatory records. The role works under a regulatory affairs manager. A good one compiles accurate, complete dossiers on time, keeps track of every licence and deadline, spots gaps before they cause delays, and learns the regulations well enough to take on more complex submissions and grow into a manager role.
Key responsibilities
- Compile and prepare dossiers and submission documents for product approvals.
- Prepare and submit applications to CDSCO and state licensing authorities.
- Track product licences, registrations and renewal due dates so none lapse.
- Help prepare responses to regulatory queries and deficiency letters.
- Review labels, artwork and packaging inserts for regulatory compliance.
- Maintain regulatory records, files and trackers accurately for every assigned product.
- Coordinate documents and data from development, quality and other teams.
- Support post-approval changes and variation filings with the required documents and data.
- Track regulatory guidelines and updates relevant to the products.
- Keep regulatory documentation complete, organised and ready for any inspection.
Requirements
- B.Pharm or M.Pharm, or a life science degree
- Basic knowledge of regulatory processes
- A regulatory affairs course is an advantage
- 1 to 4 years in regulatory affairs
KRAs and KPIs for a Regulatory Affairs Officer
Key result areas for the appraisal form, each with a KPI you can measure every month or quarter.
| Key result area | How to measure it |
|---|---|
| Submission accuracy | Dossiers compiled complete and accurate, with minimal queries |
| Licence tracking | All licences and renewals tracked, with zero lapses |
| On time filing | Submissions and renewals filed by their due dates |
| Query support | Query responses compiled accurately within the required time |
| Documentation | Regulatory records complete, accurate and inspection-ready |
| Learning | Take on more complex submissions over the period |
Skills and tools
Tools used day to day: eCTD or submission software, Regulatory databases, MS Office, Document management systems, Licence trackers.
Reporting line and career path
Next roles: Regulatory Affairs Manager, Senior Regulatory Affairs Officer
Interview questions for a Regulatory Affairs Officer
- What documents go into a product dossier and how do you organise them?
- How do you track licences and renewals so none lapse?
- How do you check a dossier is complete before submission?
- How do you help prepare a response to a deficiency letter?
- What do you review on a product label for compliance?
- How do you keep regulatory files ready for an inspection?
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What does a regulatory affairs officer do?
A regulatory affairs officer prepares and compiles the documents that get pharmaceutical products approved and keep them compliant. They assemble dossiers, prepare submissions to authorities like CDSCO, track licences and renewals, help answer queries, and maintain regulatory records. They keep submissions accurate and complete and every licence and deadline on track.
How do I start a career in regulatory affairs?
A B.Pharm or M.Pharm, or a life science degree, is the usual entry, and a regulatory affairs course helps. Start as a regulatory trainee or officer, learn to compile dossiers and track licences, and build knowledge of the approval process. With experience you move up to regulatory affairs manager and beyond.
What skills does a regulatory affairs officer need?
A regulatory affairs officer needs dossier compilation, submission and licence-tracking skills, plus knowledge of regulatory processes and labelling review. Attention to detail is essential, since incomplete or wrong documents delay approvals. Good coordination helps, because the role gathers documents and data from development, quality and other teams for each submission.