Job Description
Job Objective :-
Registration Document Compilation, verification, review and to provide support to marketing throughout the registration cycle of assigned countries.
RESPONSIBILITIES:-
• 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
• 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.
Job Location: Mumbai- Western Suburbs
Salary:
INR 3,00,000 - 3,75,000 P.A
Industry:
Pharma, Biotechnology, Clinical Research
Functional Area:
Healthcare, Medical, R&D
Role Category:
Drug Regulatory Affairs/ Documentation
Role:
Regulatory Affairs Manager
Keyskills:
Regulatory, , regulatory affairs, regulations
Desired Candidate Profile
Education:
Please refer to the Job description above(UG - B.Pharma) AND (PG - Any PG Course)
Company Profile
Pinnacle Manpower Resources
A fast growing pharmaceutical specialty products manufacturing company. It has a comprehensive range of Oncology (Anti Cancer) products. It operates in domestic as well as overseas marketsIf above Post not related to you please forward to your friends..because its CAREER Matter. Refer
www.pharmanaukri.info
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