Sun Pharmaceutical Industries Ltd has announced an exciting opportunity for experienced pharma professionals in Regulatory Affairs. The company is hiring for the position of Executive – Regulatory and Business Continuity at its R&D Regulatory Affairs division in Baroda, Gujarat. Candidates with an M.Pharm qualification and 2–4 years of regulatory affairs experience are encouraged to apply.
This latest Sun Pharma Regulatory Affairs job opening is ideal for professionals looking to build a rewarding career in pharmaceutical regulatory submissions, dossier compilation, CMC documentation review, clinical trial documentation, and regulatory compliance for India market approvals.
Job Highlights
| Particulars | Details |
|---|---|
| Job Title | Executive – Regulatory Affairs |
| Company | Sun Pharmaceutical Industries Ltd |
| Department | R&D1 Regulatory Affairs |
| Location | Baroda (Vadodara), Gujarat |
| Qualification | M.Pharm |
| Experience | 2–4 Years |
| Employment Type | Full-Time |
| Industry | Pharmaceutical / Regulatory Affairs |
| Salary | ₹5.5 LPA – ₹8.5 LPA (Estimated) |
About Sun Pharma
Sun Pharma Careers is one of India’s leading pharmaceutical companies with a strong global presence in specialty generics, formulations, APIs, and innovative healthcare solutions. The company offers excellent career growth opportunities, learning exposure, and a collaborative work environment for pharma professionals.
At Sun Pharma, employees are encouraged to “Create Your Own Sunshine” through continuous learning, leadership opportunities, and teamwork-driven success.
Key Responsibilities
The selected candidate for the Executive – Regulatory Affairs role will be responsible for:
- Evaluating regulatory strategies for products to be registered in India
- Coordinating with cross-functional teams for regulatory documentation
- Reviewing CMC documents as per regulatory guidelines
- Reviewing specifications for bulk drugs and formulations
- Reviewing clinical trial and bioequivalence study documents
- Conducting literature searches for regulatory application strategies
- Preparing safety and efficacy rationales for new drugs and FDCs
- Preparing executive summaries for SEC referrals
- Compiling dossiers for regulatory submissions
- Filing ND/SND/FDC applications through the SUGAM portal
- Reviewing labels, cartons, and prescribing information
- Ensuring compliance with Indian regulatory requirements
Required Qualifications
Candidates applying for this Sun Pharma Regulatory Affairs job should possess:
- Educational Qualification: M.Pharm
- Experience: 2–4 years in Regulatory Affairs
- Strong understanding of:
- CMC documentation
- Regulatory dossier compilation
- SUGAM portal submissions
- Clinical trial and bioequivalence documentation
- Indian pharma regulatory guidelines
Preferred Skills
- Excellent documentation and analytical skills
- Knowledge of regulatory submission processes in India
- Ability to coordinate with cross-functional teams
- Literature review and data interpretation skills
- Strong communication and organizational abilities
Benefits of Working at Sun Pharma
Sun Pharmaceutical Industries Ltd offers several career and employee benefits, including:
- Competitive salary package
- Career growth opportunities in Regulatory Affairs
- Exposure to global pharmaceutical standards
- Learning and development programs
- Collaborative and innovation-driven work culture
- Employee wellness and professional support initiatives