Regulatory Affairs Executive
Hetvi Lifesciences · Ahmedabad · posted 1 month ago
₹5 L – ₹7.5 L
per year
- Type:
- Full-time
- Workplace:
- On-site
- Experience:
- 2–4 yrs
- Vacancies:
- 2
- Apply by:
- 21 Sep 2026
- Qualification:
- Postgraduate
About the role
Hetvi Lifesciences manufactures and markets pharmaceutical formulations in India and exports to Africa, CIS and Southeast Asian markets. Our Ahmedabad regulatory affairs team is hiring an executive for dossier preparation and lifecycle management. You will compile CTD and ACTD dossiers for export registrations, respond to ministry queries, manage renewals and post-approval variations, and coordinate with plant QA for documents such as stability data and process validation summaries. M.Pharm or equivalent with two to four years in regulatory affairs for semi-regulated markets is required; exposure to WHO-GMP inspection documentation is an advantage.
Responsibilities
- Compile and submit CTD and ACTD dossiers for export markets
- Respond to health-ministry queries within committed timelines
- Manage registration renewals and post-approval variation filings
- Coordinate stability, validation and artwork documents with plant teams
- Maintain the registration tracker across 20-plus markets
- Support regulatory due diligence for new market entries
Required skills
- Microsoft Excel
- Data Analysis
- Quality Control
- Communication Skills
About the company
Hetvi Lifesciences
Pharmaceuticals & Life Sciences · 1001-5000 employees · Ahmedabad
Hetvi Lifesciences manufactures generic formulations and active pharmaceutical ingredients at three plants near Ahmedabad and Ankleshwar, supplying regulated markets including the US, UK and South Africa alongside domestic sales. The corporate office and R&D centre are in Ahmedabad, where formulation scientists work on extended-release and topical products. The company holds approvals from major regulatory agencies and runs continuous audit-readiness programmes. It hires pharmacy and chemistry graduates through campus programmes and plant engineers through apprenticeships, with clear progression from officer to executive grades.
Company website