Sun Pharmaceutical Industries Ltd. is a leading global pharmaceutical company headquartered in Mumbai, India. It is one of the largest generic pharmaceutical companies in the world and has a strong presence in both domestic and international markets.
We are Hiring
Department: Regulatory Affairs (US & OAM)
Job Location: Baroda
Experience: 3-6 years
Qualification: M. Pharm
Brief JD:
1) Review all data and documents related to product registrations for various health authorities (NON oral is preferable)
2) Compile registration dossiers for submission to various health authorities like – US, Canada, Europe, Australia.
3) Prepare responses to deficiency letters received from various agencies.
4) Maintain life-cycle / post approval changes for drug product registration dossiers.
5) Provide regulatory support to cross functional departments.
6) Prepare and submit scientific advice to various health authorities.
7) eCTD compilation, verification and submission through electronic gateway
Department: MS&T-Injectable
Job Location: Halol
Experience: 1-7 years
Qualification: B.Pharm/ M.Pharm
Brief JD:
1. Execution of technology transfer to Sun/CMO Site transfer, Scale up, Exhibit, Process validation batches plan with effective planning and utilization of men, materials and machineries.
2. Documentation work like new production introduction form, Scale-up reports, review of Sun/CMO BMR, sampling plan, PV protocol, URS preparation, and Dashboard preparation.
3. To ensure that product is produced and stored according to the appropriate documentation in order to obtain the desired quality.
4. Responsible for Review & comments of MF, FMEA, RA & protocol (Sampling plan, Process validation protocol) and compliance
Send your resume at: [email protected]
