Zenith Drugs Ltd Hiring for Regulatory Affairs (RA) Department – Apply for RA Manager Position
Zenith Drugs Ltd, a leading WHO-GMP certified pharmaceutical manufacturing company with over two decades of industry excellence, is now hiring for the position of Regulatory Affairs Manager. This is a great opportunity for professionals with strong experience in regulatory guidelines, dossier compilation, compliance management, and MOH submissions.
 About Zenith Drugs Ltd
With more than 20 years of service, Zenith Drugs Ltd is recognized as one of the most trusted pharmaceutical manufacturers by healthcare professionals and government health institutions. The company holds a strong manufacturing portfolio that includes:
- Oral Liquids
- External Liquids
- External Semisolids
- Oral Powders
- Hard Gelatin Capsules
- Injectables (under construction)
Zenith also excels in producing Oral Rehydration Salts (ORS) and is one of the largest ORS manufacturers in Central India. Trusted by pharma giants such as Ajanta Pharma, Micro Labs, May & Baker, Kopran, the company consistently supplies quality medicines across 10+ Indian states.
Internationally, Zenith Drugs exports pharmaceuticals to Angola, Bhutan, Chile, Cambodia, Costa Rica, Dominican Republic, DR Congo, Guyana, Myanmar, Nepal, Nigeria, Seychelles, Sierra Leone, Somalia, Swaziland, Venezuela, Yemen and more.
The company operates with two subsidiary divisions:
✔ Biozen Healthcare
✔ Biogenesis Corporation
Vacancy Details – Regulatory Affairs Manager
Position: Regulatory Affairs Manager
Department: Regulatory Affairs (RA)
Job Overview
Zenith Drugs Ltd is expanding its Regulatory Affairs Department and is seeking an experienced professional who understands global and local regulatory requirements, dossier preparation, compliance standards, and marketing authorization submissions.
Key Responsibilities:
- Prepare, review, and submit documentation for MOH registration (conventional, herbal, medical devices).
- Manage eCTD submissions, regulatory updates, classification, QCL, and registration follow-ups.
- Prepare and follow up on Marketing Authorization applications as per guidelines.
- Review regulatory clauses and coordinate with the legal team for approvals.
- Work closely with principals to ensure compliance with new and existing regulations.
- Coordinate with commercial teams for timely product launches and renewals.
- Support regulatory planning and departmental activities as per timelines.
Required Qualifications
- B.Pharma or Life Science degree (mandatory).
- 10+ years of experience in pharmaceutical regulatory affairs.
- Strong communication skills (verbal & written English).
- Proficient in MS Word, Excel, and PowerPoint.
Job Facilities:
- TA/DA
- Provident Fund (PF)
- ESIC
- Gratuity
- Bonus
What’s in Store?
- Immense learning & development opportunities
- Fast-track path to First-Line Manager and above
- Attractive incentive earning opportunities
- International travel exposure
How to Apply?
Send your updated CV to:
hrsales@zenithdrugs.com
+91 9827351180
+91 7723816657
