Dear All now get GMP News, FDA, WHO, EU, TGA, CDSCO guidelines...and GMP Violations news/warning letters.. GMPVIOLATIONS

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.

• 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
INR 3,00,000 - 3,75,000 P.A
Pharma, Biotechnology, Clinical Research
Functional Area:
Healthcare, Medical, R&D
Role Category:
Drug Regulatory Affairs/ Documentation
Regulatory Affairs Manager
Regulatory, , regulatory affairs, regulations
Desired Candidate Profile
(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

If above Post not related to you please forward to your friends..because its CAREER Matter. Refer


Post a Comment

Related Posts Plugin for WordPress, Blogger...
Enter your email address: Updated Regularly || Click here for Get Free SMS Alerts |


 Jobs By Category

Manufacturing/Production     Quality Control    Quality Assurance

Regulatory Affairs     Research & Development     Clinical Research

Warehouse/Stores HR Jobs     Contract Manufacturing     Supply Chain / PPIC

Purchase jobs      Marketing PharmacoVigilance 

 Jobs By Location

Baddi     Bhopal     Chandigarh     Solapur     Hosur     Gangtok     Gurgaon    

Mohali     Baroda Ankleshwar     Ahmedabad     Delhi      Mumbai      Chennai    

Hyderabad     Bangalore     Goa     Gujarat      Pune    

 Jobs By Qualification  

Ph.D     M.Sc     MBBS     M.Pharmacy     MBA     M.Com      M.Tech     B.Tech     

B.Pharmacy      B.Sc     D.Pharmacy     B.Com     Intermediate   Any Graduate      

ITI     SSC    

Jobs for Freshers


Enter Key word then search


Twitter Delicious Facebook Digg Stumbleupon Favorites