Zenith Drugs, a fast-growing pharmaceutical manufacturing and trading company based in Indore, Madhya Pradesh, is hiring an experienced Regulatory Executive to support global product registrations and international market expansion. This opportunity is ideal for regulatory professionals with hands-on experience in CTD/ACTD dossier preparation, variations, and country-specific submissions across Southeast Asia, Africa, LATAM, and CIS regions.
If you are seeking a long-term career in pharmaceutical regulatory affairs with exposure to global markets, this role offers strong growth potential and stability.
🏢 About Zenith Drugs
Established in 2000, Zenith Drugs specializes in branded, generic, and OTC pharmaceutical products including ORS powder, liquid orals, ointments, externals, capsules, and injectables. The company focuses on safety, efficacy, affordability, and is preparing to become one of the first pharma companies listed on NSE.
📌 Job Details
- Position: Regulatory Executive
- Location: Indore, Madhya Pradesh
- Employment Type: Full-time
- Industry: Pharmaceutical Manufacturing
🔧 Key Responsibilities
- Prepare and compile registration, re-registration, and variation dossiers for multiple countries
- Develop Finished Product Dossiers (CTD/ACTD) for tablets, capsules, injectables, eye/ear drops, dry syrup, suspension, sachets, and PFS
- Review artworks for compliance with country-specific guidelines
- Coordinate with Marketing for dossier inputs, queries, and registration status
- Arrange dispatch of product samples and supporting documents
- Review DMF and coordinate with API vendors to resolve queries
- Maintain regulatory trackers, aging analysis, and archival records
- Submit GMP applications for various countries on time
- Handle tender documentation (Ethiopia, Kenya, and other African markets)
- Participate in monthly planning and management review meetings
🎓 Qualifications & Experience
- Bachelor’s degree in Pharmacy or Life Sciences (mandatory)
- 4–6 years of regulatory affairs experience in pharmaceutical industry
- Experience with Southeast Asia, West Africa, LATAM, CIS markets preferred
- Strong written and spoken English communication
- Proficiency in MS Word, Excel, and PowerPoint
💰 Salary & Benefits
- Estimated Salary Range: ₹5,00,000 – ₹8,00,000 per annum
- Exposure to global regulatory markets
- Stable career growth in expanding organization
- Professional work environment
📍 Work Location
Corporate Office:
210 B, Scheme No. 134, Star Square, Nipania, Indore – 452010
Factory:
Muradpura (Orangpura), Dhar Road, Near Kalaria, Indore – 453001
📧 How to Apply
Send your updated CV to:
Hrsales@zenithdrugs.com