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Friday, April 6, 2012

Executive Regulatory Affairs - by Pinnacle Manpower Resources in Mumbai


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 


• 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:
(UG - B.Pharma) AND (PG - Any PG Course)
Please refer to the Job description above
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 markets
Contact Details
Executive Name:
Mr Bhosle





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