Naprod Lifesciences invites for Assistant Manager in regulatory affairs

Naprod’s vision is to become a world class player in oncology through excellence in innovation, discovery of new manufacturing processes / drug delivery mechanisms and consistently high quality of production. We commenced operations in 1994 with the inauguration of our ultra-modern facility for the production of generics and formulations for oncology and other therapeutic applications. We are one of the pioneers in India in lyophilization.

Post: Assistant Manager - Regulatory Affairs

Job Description:
• To study and update Regulatory guideline of assigned countries and to prepare checklist / template for registration dossier.
• To verify specification of excipients , active , finished product and packaging material and all required documents.
• Application, review, co-ordination, follow-up of legal documents COPP , FSC etc.
• Maintain Proper database w.r.t to master document dossier.
• To collect and verify all technical documents and information from various departments at the manufacturing site and R & D site.
• To prepare and compile registration dossier as per the guidelines and checklist and submit to marketing to further submission to regulatory authorities.
• Regulatory support to various departments.
• Review follow-up and co-ordination for registration samples /WS and impurities required for analysis purpose.
• To prepare , review compile re-registration documents.
• To prepare review , compile and co-ordination for documents required for company registration and Tender purpose.
• To study ,review variation guidelines of assigned countries and submit variation documents as per the guidelines.
• To maintain and update Registration certificate /information in regulatory data base.

Candidate Profile:
B. Pharma OR M. Pharma.
PLEASE NOTE: JOB LOCATION WILL BE BASED AT SAKI NAKA, ANDHERI EAST.
ONLY MUMBAI CANDIDATES WILL BE PREFERRED.

Additional Information:
Experience: 3-6 Years
Location: Mumbai
Education: B.Sc, B.Pharm, M.Pharm
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: DRA
End Date: 24^th July, 2012
Salary: 3 - 4.5 laks/anum