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Scientist - Regulatory Affairs - EU/ROW - Delhi/NCR

The application deadline for this job posting has passed. Although you can still view the information no new applications for this job are currently being accepted.

By Anonymous - Posted on 20 May 2009

Reference: JOB387
Location: India
Application deadline: CLOSED
Contact: Miss Soniya

“A Reputed Client of TBC Consultant”

 

 

 

Experience: 3 - 8 Years

Location: Delhi/NCR

Education:  UG - B.Pharma - Pharmacy

                      PG - M.Pharma - Pharmacy

Industry Type:  Pharma/ Biotech/Clinical Research

Functional Area: Healthcare, Medical, R&D

Salary:  Best in the Industry

Job Description: -

-M.Pharm with 4-8 years of experience in Regulatory Affairs
-Knowledge of Regulatory filing requirements for South Africa,/Russia/ CIS countries/Brazil/ Mexico &EU
-Preparation of Dossier Submissions for EU/South Africa,/Russia/ CIS countries/Brazil/ Mexico
-Knowledge of compiling Dossiers in different formats such as PDF, CTD and eCTD formats.
-Maintenance of Regulatory Database Management System or any other equivalent tools.
-Coordinate with manufacturing locations and various departments of R&D for requisite data generation and subsequent filing in respective countries.
-Updation of requisite regulatory information & guidelines of regulatory authorities of various countries to ensure preaparation of quality dossiers.
-To maintain & update database for easy retrieval of documents and information
-Documentation Maintenance includes retrieval of regulatory submissions, indexing and retrievals both electronic and hardcopy.

Desired Candidate Profile:-

M.Pharm with 4-8 years of experience in Regulatory Affairs of EU/ROW regions.

Company Profile:-

“A Reputed Client of TBC Consultant” is a progressive and quality conscious multi-national organization serving the pharmaceutical needs of diverse markets around the globe comprising of developing, emerging and advanced countries. It is ranked amongst the top ten global generic companies and has a presence in 23 of the top 25 pharma markets of the world. The Company with a global footprint in 49 countries, world-class manufacturing facilities in 11 and a diverse product portfolio, is rapidly moving towards global leadership, riding on its success in the world’s emerging and developed markets.

Contact Details:-

Company Name: “A Reputed Client of TBC Consultant”

Contact Person:  Miss Soniya

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