Vacancy for B.Pharm, M.Pharm in Regulatory Affairs, MS&T Injectable at Sun Pharma

Sun Pharmaceutical Industries limited is the largest specialty generic pharmaceutical company in the world. We provide high quality, affordable medicine trusted by healthcare professionals and patients in over ISO countries. It is also India's largest, most trusted and most valuable pharmaceutical company by market capitalisation.

Regulatory Affairs ; MS&T - Injectable

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

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