Company Overview: Sun Pharmaceutical Industries Ltd. is the largest specialty generic pharmaceutical company globally, known for providing high-quality, affordable medicines. We are India’s most trusted and valuable pharmaceutical company by market capitalization, serving healthcare professionals and patients in over 150 countries.
Positions Available:
1. Regulatory Affairs (US & OAM)
Location: Baroda
Experience: 3 – 6 years
Qualification: M.Pharm
Key Responsibilities:
- Review data and documents related to product registrations for various health authorities (preferably non-oral).
- Compile registration dossiers for submission to agencies such as the US FDA, Health Canada, EMA, and TGA.
- Prepare responses to deficiency letters from health authorities.
- Manage lifecycle/post-approval changes for drug product registration dossiers.
- Provide regulatory support to cross-functional departments.
- Prepare and submit scientific advice to health authorities.
- eCTD compilation, verification, and submission via electronic gateways.
2. MS&T – Injectable
Location: Halol
Experience: 1 – 7 years
Qualification: B.Pharm / M.Pharm
Key Responsibilities:
- Execute technology transfers to Sun/CMO sites, scale-up, and process validation batch planning.
- Documentation tasks including new product introduction forms, scale-up reports, and compliance documentation.
- Ensure products are produced and stored according to appropriate documentation to achieve desired quality.
- Review and comment on Master Files (MF), Failure Mode and Effects Analysis (FMEA), and protocols for sampling plans and process validations.
Application Process: Interested candidates can send their resumes to Rosemary.varghese@sunpharma.com
Last Date for Applications: 25th October 2024
