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Opening for Sr Executive / Asst. Manager -regulatory Affairs at Hyderabad

By: JobSearch | Views: 988 | Date: 08-Jan-2013

Opening for Sr Executive / Asst. Manager -regulatory Affairs at Hyderabad in 2013.Regulatory Affairs EU - Formulations.(UG - B.Pharma - Pharmacy) AND (PG - M.Pharma - Pharmacy) OR ( Doctorate - Ph.D - Pharmacy)

Sr Executive / Asst. Manager -regulatory Affairs (EU - Formulations)
by Aurobindo Pharma Ltd in Hyderabad / Secunderabad

Experience: 5 to 8 yrs.  

Opening(s): 1

Posted on: 05 Jan

Job Description,

Should be experience in filling the dossiers for EU market in ECTD format

Submission of registration dossiers in CTD format as per ICH guidelines for filing application with various Regulatory Agencies in European continent via DCP / MRP procedures.

Preparation of effective query replies raise by various Regulatory Agencies of Europe.

Key role in finalization of technical documents at various stages of product development.

Review of technical quality documents on receipt from different locations before inclusion in dossiers and query responses.

Handling Post-registration activities like Variations, Preparation of Approval Packages, RPPs.

Responsible for regulatory support for new product developments

Experience in all modules (M 1 to M -5)

Salary:

Best in the Industry

Industry:

Pharma / Biotech / Clinical Research

Functional Area:

Legal, Regulatory, Intellectual Property

Role Category:

Drug Regulatory Affairs/Documentation

Role:

Regulatory Affairs Manager

Keyskills:

Regulatory Affairs EU - Formulations

Desired Candidate Profile
Education:

(UG - B.Pharma - Pharmacy) AND (PG - M.Pharma - Pharmacy) OR ( Doctorate - Ph.D - Pharmacy)

Please refer to the Job description above
Company Profile
Aurobindo Pharma Ltd 
http://www.aurobindo.com
$1B Pharma giant
Contact Details
Recruiter Name:

viswanadh.kandala@aurobindo.com

Contact Company:

Aurobindo Pharma Ltd

Telephone:

08455223700

Reference Id:

R&D1/RAD- EU/051377

To Apply Please Visit:http://jobsearch.naukri.com/job-listings-Sr-Executive-Asst-Manager-regulatory-Affairs-EU-Formulations--Aurobindo-Pharma-Ltd-Hyderabad-Secunderabad-5-to-8-050113002437

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