Looking to build a strong career in Regulatory Affairs in the pharmaceutical industry? Here’s an excellent opportunity with Sun Pharmaceutical Industries Ltd, one of India’s leading pharma companies. The company is hiring for the role of Executive – Regulatory Affairs at its Baroda (Vadodara) R&D center, focusing on MENA and South Africa markets.
This role is ideal for candidates with 1–4 years of experience in regulatory submissions, CMC dossier preparation, and lifecycle management.
Job Overview
- Job Title: Executive – Regulatory Affairs
- Company: Sun Pharmaceutical Industries Ltd
- Location: Baroda (Vadodara), Gujarat
- Department: R&D Regulatory Affairs
- Experience: 1–4 Years
- Qualification: M.Pharm / M.Sc
- Job Type: Full-Time
Key Responsibilities
1. Regulatory Submissions & Renewals
- Prepare and review CMC (Chemistry, Manufacturing & Controls) dossiers for new submissions
- Evaluate development reports, scale-up reports, specifications, and stability protocols
- Ensure readiness of documentation before exhibit batch initiation
2. Regulatory Approval Process
- Draft and review responses to regulatory queries/deficiencies
- Support timely product approvals across international markets
3. Lifecycle Management
- Handle post-approval variations including:
- API vendor changes
- Test parameter updates
- Drug formulation site changes
- Ensure compliance with country-specific regulatory requirements
4. Regulatory Compliance
- Maintain product approval documentation and history sheets
- Update central regulatory repositories
- Assess impact of change controls and variations on filings
5. Market Focus
- Primarily responsible for South Africa and MENA regulatory markets
Eligibility Criteria
- Educational Qualification: M.Pharm / M.Sc (Life Sciences/Pharmaceutical Sciences)
- Experience: 1–4 years in Regulatory Affairs (pharma)
- Strong understanding of:
- CMC documentation
- Regulatory submissions
- Lifecycle management processes
Salary & Benefits
- Estimated Salary: ₹4,00,000 – ₹8,00,000 per annum
- Career growth in a leading pharmaceutical company
- Exposure to global regulatory markets (MENA & South Africa)
- Collaborative and growth-oriented work environment
- Learning and development opportunities
Why Join Sun Pharma?
Sun Pharma promotes a culture of:
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- Continuous growth (“Better every day”)
- Ownership and leadership (“Take charge”)
- Team collaboration (“Thrive together”)
This makes it a strong platform for professionals aiming to advance in Regulatory Affairs careers in India.
How to Apply
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