Sun Pharmaceutical Industries Ltd is inviting applications for the position of Executive – Regulatory Affairs (R&D1 Regulatory Affairs) at its Tandalja R&D center, Baroda. This opportunity is ideal for M.Pharm/M.Sc professionals with 1–4 years of experience in regulatory affairs, CMC dossier preparation, lifecycle management, and MENA market submissions.
If you are looking to build a career in Regulatory Affairs for MENA markets, particularly handling South Africa regulatory submissions, this role offers strong exposure to global filings, variations, renewals, and compliance management.
📌 Job Overview
- Position: Executive – Regulatory Affairs
- Company: Sun Pharmaceutical Industries Ltd
- Location: Baroda (Tandalja – R&D)
- Business Unit: R&D1 Regulatory Affairs
- Grade: G12A
- Experience: 1–4 Years
- Qualification: M.Sc / M.Pharm
- Geographic Scope: South Africa (MENA Markets)
🎯 Key Responsibilities
1️⃣ Regulatory Submissions (New & Renewals)
- Prepare and review CMC (Chemistry, Manufacturing & Controls) dossiers for fresh submissions.
- Review development reports, scale-up reports, specifications, and stability protocols.
- Ensure artwork and documentation adequacy before exhibit batch initiation.
- Handle regulatory submissions for MENA markets including South Africa.
2️⃣ Deficiency Response & Approvals
- Prepare responses to regulatory agency deficiency queries.
- Coordinate documentation to enable timely product approvals.
- Maintain accuracy and compliance in submission responses.
3️⃣ Lifecycle Management (LCM)
- Prepare and review regulatory variations:
- API vendor changes
- ROS/test parameter updates
- Drug formulation (DF) site changes
- Product harmonization
- Ensure country-specific compliance for South Africa regulatory filings.
4️⃣ Regulatory Compliance & Documentation
- Circulate approval packages with product history sheets to stakeholders.
- Update central regulatory repositories.
- Review filing impact of change controls and variations.
- Maintain comprehensive product lifecycle documentation.
This Executive – Regulatory Affairs role at Sun Pharma demands strong expertise in CMC documentation, regulatory compliance, and lifecycle management for drug formulations.
🎓 Educational Qualification
- M.Pharm or M.Sc (Relevant specialization)
💼 Experience Required
- 1–4 years in:
- Regulatory Affairs
- CMC dossier preparation
- MENA or South Africa submissions
- Pharmaceutical lifecycle management
- Variation filings and deficiency responses
💰 Salary (Estimated)
Based on industry benchmarks for Executive – Regulatory Affairs roles in Baroda:
- ₹5.5 LPA – ₹8.5 LPA (Approx.)
(Final compensation will depend on candidate experience and company policy.)
🌍 Why Join Sun Pharma?
- Exposure to global regulatory submissions (MENA & South Africa)
- Strong R&D regulatory framework
- Experience in lifecycle management and variations
- Structured documentation systems and central repositories
- Career progression within regulatory affairs
Sun Pharma emphasizes continuous growth, cross-functional collaboration, and structured regulatory excellence—making it a strong platform for regulatory professionals aiming for global exposure.
📩 How to Apply?
