| Detail | For this role |
|---|---|
| Department | Pharma |
| Level | Entry level |
| Reports to | Regulatory Affairs Officer |
| Direct reports | None |
| Experience | Fresher or up to 2 years in regulatory affairs or QA |
Regulatory Affairs Executive 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 Executive
Department: Pharma
Reports to: Regulatory Affairs Officer
Location: [City], [office, branch or site]
About the role
A Regulatory Affairs Executive is the entry role in regulatory affairs, supporting submissions and compliance for pharmaceutical products. They collate documents and data, help compile dossiers, maintain trackers and records, and support licence renewals and queries under an officer or manager. The role is a start in regulatory affairs. A good one collates accurate, complete documents on time, keeps trackers and records in order, learns the approval process quickly, and grows into a regulatory affairs officer who can compile full dossiers on their own.
Key responsibilities
- Collate documents and data from various teams for dossiers and submissions.
- Help compile and format dossier sections under the guidance of an officer.
- Maintain regulatory trackers for licences, renewals and submission timelines accurately.
- Support licence renewal applications by gathering the required documents.
- Help prepare responses to regulatory queries by collecting supporting data.
- Check documents for completeness against submission checklists before they are compiled.
- File and archive regulatory records so they are easy to retrieve.
- Coordinate with quality, production and development teams for documents.
- Track regulatory updates and share relevant ones with the team.
- Support labelling and artwork checks for regulatory compliance on assigned products.
Requirements
- B.Pharm or M.Pharm, or a life science degree
- Interest in regulatory affairs
- A regulatory affairs course is an advantage
- Fresher or up to 2 years in regulatory affairs or QA
KRAs and KPIs for a Regulatory Affairs Executive
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 |
|---|---|
| Document collation | Documents collated complete and accurate against submission checklists |
| Tracker accuracy | Licence and submission trackers kept accurate and current |
| On time support | Submission and renewal support delivered by the required dates |
| Record keeping | Regulatory records filed correctly and easy to retrieve |
| Coordination | Documents gathered from teams without avoidable delays |
| Learning | Take on dossier compilation independently over the period |
Skills and tools
Tools used day to day: MS Office, Document management systems, Regulatory trackers, eCTD viewers, Email.
Reporting line and career path
Next roles: Regulatory Affairs Officer, Regulatory Affairs Manager
Interview questions for a Regulatory Affairs Executive
- What documents typically go into a product dossier?
- How do you keep a licence renewal tracker accurate?
- How do you check that a set of documents is complete before submission?
- How do you coordinate documents from several teams for a deadline?
- Why is accuracy so important in regulatory submissions?
- Why do you want to build a career in regulatory affairs?
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What does a regulatory affairs executive do?
A regulatory affairs executive is the entry role in regulatory affairs, supporting submissions and compliance. They collate documents and data, help compile dossiers, maintain trackers and records, and support licence renewals and queries under an officer or manager. They keep documents complete and trackers accurate while learning the approval process.
What is the difference between a regulatory affairs executive and officer?
A regulatory affairs executive is the more junior role, collating documents, maintaining trackers and supporting dossiers under guidance. An officer compiles full dossiers, handles submissions and licences, and answers queries with more independence. The executive learns the process and supports; the officer owns the compilation and filing work.
How do I become a regulatory affairs executive?
A B.Pharm, M.Pharm or life science degree is the usual entry, and a regulatory affairs course helps you stand out. Employers hire freshers who are detail-focused and organised. Start by collating documents and maintaining trackers, learn the approval process, and grow into officer and manager roles with experience.