| Detail | For this role |
|---|---|
| Department | Pharma |
| Level | Manager |
| Reports to | Head of Regulatory Affairs |
| Direct reports | Regulatory Affairs Officer |
| Experience | 6 to 10 years in regulatory affairs, with some team responsibility |
Regulatory Affairs Manager 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 Manager
Department: Pharma
Reports to: Head of Regulatory Affairs
Location: [City], [office, branch or site]
About the role
A Regulatory Affairs Manager manages the approval and compliance of a set of pharmaceutical products. They plan and prepare dossiers, make submissions to authorities, manage approvals, licences and post-approval changes, and answer regulatory queries. The role leads regulatory officers and reports to the head of regulatory affairs. A good one gets products approved on time with clean dossiers, keeps licences current, handles authority queries well, and guides the business on what the regulations allow, all while keeping submissions accurate and audit-ready.
Key responsibilities
- Plan and manage regulatory submissions and approval timelines for assigned products.
- Prepare, review and submit dossiers and applications to CDSCO and state authorities.
- Manage product registrations, licences and their renewals so none lapse.
- Handle post-approval changes, variations and labelling updates with the authorities.
- Respond to regulatory queries and deficiency letters within the required time.
- Review labels, packaging and promotional material for regulatory compliance.
- Guide product and development teams on regulatory requirements for filings.
- Track regulatory changes and assess their impact on assigned products.
- Lead and review the work of regulatory officers on submissions.
- Keep regulatory records and documentation complete, accurate and ready for any inspection.
Requirements
- B.Pharm or M.Pharm, or a life science degree
- Solid experience in pharma regulatory affairs
- Strong knowledge of Indian drug approval processes
- 6 to 10 years in regulatory affairs, with some team responsibility
KRAs and KPIs for a Regulatory Affairs Manager
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 |
|---|---|
| Approval timelines | Assigned product approvals obtained within the planned timelines |
| Licence compliance | All assigned licences and registrations current, with zero lapses |
| Submission quality | Dossiers accepted with minimal queries or deficiencies |
| Query response | Regulatory queries answered within the required time |
| Compliance | Assigned products compliant, with no major regulatory findings |
| Team output | Officers guided so submissions are delivered accurately and on time |
Skills and tools
Tools used day to day: Regulatory submission software, eCTD publishing tools, Regulatory databases, MS Office, Document management systems.
Reporting line and career path
Next roles: Head of Regulatory Affairs, Director Regulatory Affairs
Interview questions for a Regulatory Affairs Manager
- How would you plan the submission for a new product to meet a launch date?
- How do you keep several product licences current without a lapse?
- How do you respond to a deficiency letter from the regulator?
- How do you handle a post-approval change to a product's formulation?
- How do you guide the product team when a claim needs regulatory support?
- How do you review a dossier to reduce queries from the authority?
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What does a regulatory affairs manager do?
A regulatory affairs manager manages the approval and compliance of a set of pharmaceutical products. They plan and prepare dossiers, make submissions to authorities, manage approvals, licences and post-approval changes, and answer regulatory queries. They lead regulatory officers, review material for compliance, and guide the business on regulatory requirements.
What is the difference between a regulatory affairs officer and a manager?
A regulatory affairs officer prepares dossiers, compiles documents and handles submissions under guidance. A regulatory affairs manager plans the submission strategy for products, reviews and owns the dossiers, manages licences and queries, and leads the officers. The officer does the hands-on compilation; the manager owns the approvals and the team.
What skills does a regulatory affairs manager need?
A regulatory affairs manager needs strong dossier preparation, knowledge of CDSCO and state regulations, licence management, and handling of variations and labelling. Attention to detail is vital, since small errors delay approvals. Team guidance and clear communication matter too, as the role leads officers and works with product and development teams.