Looking for the latest Regulatory Affairs jobs in India? Sun Pharmaceutical Industries Ltd has announced a new opening for the position of Executive โ Regulatory Affairs (RA) at its R&D Center in Baroda (Vadodara), Gujarat. This opportunity is ideal for M.Pharm graduates with 1โ4 years of Regulatory Affairs experience who are looking to build a rewarding career in pharmaceutical regulatory submissions, global compliance, and product registration.
Candidates with hands-on experience in USFDA regulations, ICH guidelines, CTD/eCTD submissions, ANDA, NDA, and MAA dossiers are encouraged to apply. If you’re searching for Sun Pharma Regulatory Affairs jobs, M.Pharm Regulatory Affairs vacancies, or Regulatory Affairs Executive jobs in Baroda, this opening is worth exploring.
Job Highlights
| Details | Information |
|---|---|
| Company | Sun Pharmaceutical Industries Ltd |
| Job Title | Executive โ Regulatory Affairs (RA) |
| Department | R&D โ Regulatory Affairs |
| Location | Baroda (Vadodara), Gujarat |
| Qualification | M.Pharm |
| Experience | 1โ4 Years |
| Employment Type | Full-Time |
| Industry | Pharmaceutical |
| Job Category | Regulatory Affairs |
Key Responsibilities
As an Executive โ Regulatory Affairs, you will be responsible for:
- Preparing, compiling, and submitting regulatory dossiers in CTD/eCTD formats.
- Supporting submissions for ANDA, NDA, MAA, and post-approval regulatory variations.
- Assisting in regulatory strategy development for new products and international markets.
- Monitoring updates to USFDA, ICH, EU, and Indian regulatory guidelines.
- Coordinating with cross-functional teams including R&D, Manufacturing, and CDMO.
- Preparing responses to regulatory authority queries and deficiency letters.
- Maintaining regulatory databases and monitoring submission timelines.
- Ensuring compliance with global pharmaceutical regulatory requirements.
Required Qualifications
Applicants should meet the following criteria:
- Educational Qualification: M.Pharm
- Experience: 1โ4 years in Regulatory Affairs
- Strong knowledge of:
- USFDA regulations
- ICH Guidelines
- EU and Indian regulatory requirements
- CTD/eCTD submissions
- ANDA, NDA, and MAA documentation
- Excellent communication, documentation, and coordination skills.
Preferred Skills
Successful candidates should possess:
- Regulatory dossier preparation expertise
- Pharmaceutical documentation management
- Regulatory compliance knowledge
- Analytical and problem-solving skills
- Cross-functional collaboration
- Attention to detail
- Time management
Why Join Sun Pharma?
Sun Pharma offers employees an environment focused on continuous learning and career development.
Benefits include:
- Career growth opportunities
- Exposure to global regulatory submissions
- Collaborative R&D environment
- Learning and development programs
- Opportunity to work with international regulatory standards
- Professional growth in Regulatory Affairs
Who Should Apply?
This opportunity is suitable for:
- M.Pharm graduates
- Regulatory Affairs professionals
- Candidates with CTD/eCTD submission experience
- Professionals experienced in USFDA documentation
- Candidates seeking Regulatory Affairs jobs in Gujarat
- Pharmaceutical professionals looking for global regulatory exposure
How to Apply
