Regulatory Affairs Job at Sun Pharma | M.Pharm Graduates Eligible
Looking for the latest Regulatory Affairs Job opportunity? Sun Pharma Careers has announced a vacancy for Executive – Regulatory Affairs (US Group) at its Baroda R&D facility. This Regulatory Affairs Job is an excellent opportunity for M.Pharm graduates with 2–5 years of relevant experience who are looking to build a successful career through Sun Pharma Careers in one of India’s leading pharmaceutical companies.
- Job Title: Executive – Regulatory Affairs
- Location: Tandalja – R&D
About the Company
Sun Pharmaceutical Industries Ltd is one of the world’s leading specialty generic pharmaceutical companies, committed to delivering high-quality medicines across multiple therapeutic segments. The company provides a collaborative work environment where employees are encouraged to grow professionally, take ownership of their careers, and contribute to improving global healthcare.
At Sun Pharma, employees are encouraged to “Create your own sunshine” by continuously learning, taking charge, and thriving together in a supportive workplace.
Job Description
The selected candidate will be responsible for supporting regulatory submissions, coordinating with cross-functional teams, maintaining regulatory compliance, and ensuring timely submission of regulatory dossiers for global markets.
Key Responsibilities
- Strong knowledge of USFDA, ICH guidelines, regional regulations (US, EU, India), and submission formats.
- Prepare, compile, and submit regulatory dossiers (e.g., CTD/eCTD) for new drug applications (NDAs), ANDAs, MAAs, and post-approval changes.
- Support regulatory strategy development for new products and markets.
- Coordinate with cross-functional teams (CDMO, R&D, Manufacturing) to gather required documentation and data.
- Respond to queries and deficiency letters from regulatory authorities.
- Maintain regulatory databases and track submission timelines and approvals.
Qualification
- Graduate: M.Pharm
- Experience: 2-5 years of relevant experience
Why Join This Role?
- Build your career with Sun Pharmaceutical Industries Ltd, one of the world’s leading pharmaceutical companies.
- Gain hands-on experience in US Regulatory Affairs, working with USFDA, ICH, and global regulatory requirements.
- Contribute to the preparation and submission of CTD/eCTD dossiers, NDAs, ANDAs, MAAs, and post-approval variations.
- Collaborate with cross-functional teams including R&D, Manufacturing, and CDMO, enhancing your industry exposure.
- Develop expertise in regulatory strategy, submission management, and health authority interactions.
