| Detail | For this role |
|---|---|
| Department | Pharma |
| Level | Senior management |
| Reports to | Managing Director |
| Direct reports | Regulatory Affairs Manager, Regulatory Affairs Officer |
| Experience | 12+ years in regulatory affairs, with 4 or more years leading teams |
Head of Regulatory Affairs 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: Head of Regulatory Affairs
Department: Pharma
Reports to: Managing Director
Location: [City], [office, branch or site]
About the role
A Head of Regulatory Affairs leads how a pharmaceutical company gets its products approved and keeps them compliant. They own the regulatory strategy, oversee dossiers and submissions to authorities like CDSCO and state bodies, manage approvals, licences and post-approval changes, and keep the company aligned with drug laws. The role sits in senior management and leads the regulatory team. A good one gets products approved on time, keeps every licence and registration current, avoids compliance gaps, and guides the business on what is possible within the regulations.
Key responsibilities
- Set the regulatory strategy for the product portfolio and new launches across markets.
- Oversee preparation and submission of dossiers and applications to CDSCO and state authorities.
- Manage product approvals, registrations, licences and their timely renewals.
- Handle post-approval changes, variations and labelling updates with the authorities.
- Guide the business on regulatory requirements for new products and markets.
- Keep the company aligned with the Drugs and Cosmetics rules and other applicable laws.
- Represent the company with regulators and respond to their queries and inspections.
- Review labels, packaging and promotional material for regulatory compliance.
- Track changes in regulations and assess their impact on the business.
- Build and lead the regulatory team, and set standards and training.
Requirements
- B.Pharm or M.Pharm, or a degree in a life science
- Significant experience in pharma regulatory affairs
- Strong knowledge of Indian drug regulations and approval processes
- 12+ years in regulatory affairs, with 4 or more years leading teams
KRAs and KPIs for a Head of Regulatory Affairs
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 | Product approvals and registrations obtained within planned timelines |
| Licence compliance | All licences and registrations current, with zero lapses |
| Submission quality | Dossiers accepted with minimal queries or deficiencies from authorities |
| Regulatory compliance | Zero major compliance findings in regulatory inspections and audits |
| Change management | Post-approval changes filed and cleared within the required time |
| Team capability | Regulatory team trained and delivering submissions to standard |
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: Director Regulatory Affairs, Vice President Regulatory Affairs
Interview questions for a Head of Regulatory Affairs
- How would you plan the regulatory strategy for launching a new generic product?
- How do you keep dozens of licences and registrations current without a lapse?
- How do you handle a deficiency letter or query from the regulator?
- How do you prepare the company for a regulatory inspection?
- How do you advise the business when a product idea faces regulatory hurdles?
- How do you keep the team updated as drug regulations change?
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What does a head of regulatory affairs do?
A head of regulatory affairs leads how a pharma company gets products approved and keeps them compliant. They own the regulatory strategy, oversee dossiers and submissions to authorities like CDSCO, manage approvals, licences and post-approval changes, and keep the company aligned with drug laws. They lead the regulatory team and represent the company with regulators.
What qualifications do you need for regulatory affairs in pharma?
Most regulatory affairs leaders in India hold a B.Pharm or M.Pharm, or a life science degree, plus many years of regulatory experience. Deep knowledge of the Drugs and Cosmetics rules, the approval process and CDSCO requirements is essential. Attention to detail and the ability to manage complex submissions and timelines set strong candidates apart.
What is the difference between regulatory affairs and quality assurance?
Regulatory affairs manages product approvals and compliance with drug laws: dossiers, licences and submissions to authorities. Quality assurance makes sure products are manufactured to the required quality standards through processes and checks. Regulatory affairs deals with the authorities and approvals; quality assurance deals with manufacturing quality inside the plant.