Regulatory Affairs Manager - Pharma

By: Pharma Jobs | Views: 3891 | Date: 14-May-2011

ELC Group, a Global leader in their market, is seeking a Regulatory Affairs Manager to work closely with the Regulatory Affairs teams in the support of Drug safety issues and Regulatory Compliance.This is a genuinely exciting opportunity to become part of a Global organization who are the undisputed leader in their field and who invest time and money in developing and promoting their staff internally.

ELC Group , hiring for ELC Group

Summary
 

Experience:

5 - 8 Years

Location:

Ahmedabad

Compensation:

Best in Industry.

Education:

UG - B.Pharma - Pharmacy PG - Any PG Course - Any Specialization

Industry Type:

Pharma/ Biotech/Clinical Research

Role:

Regulatory Affairs Mgr

Functional Area:

Healthcare, Medical, R&D

Posted Date:

14 May

Desired Candidate Profile

Minimum qualification B. Pharma

Work experience: Minimum 5 years in Regulatory affairs department.

Special Requirement:

Excellent English skills, both Written and Verbal

Should be able to relocate to Ahmedabad

Immediate start

 

Job Description

The candidate will have to handle following Tasks

Dossier Preparation along with skills in reviewing and compliance check of dossiers as EU and US FDA Guidelines.

Review, and Compilation of Chemistry Manufacture Control (CMC) part and formatting in CTD

Proven track record in managing DCP, MRP, ANDA, NDA

Experience with EU Variations and life cycle management

Proven experience of Preparing Dossiers in CTD and eCTD

 

Keywords: ELC group, B.Pharma, Ahmedabad, Gujarat, Regulatory Affairs, Dossier Preparation.

Company Profile

ELC Group, a Global leader in their market, is seeking a Regulatory Affairs Manager to work closely with the Regulatory Affairs teams in the support of Drug safety issues and Regulatory Compliance.
This is a genuinely exciting opportunity to become part of a Global organization who are the undisputed leader in their field and who invest time and money in developing and promoting their staff internally.
Contact Details
Company Name:

ELC Group

Executive Name:

Mr. Akhil Jain / Mr. Jastin

Address:

Not Mentioned

Email Address:

ajain@elc-group.com

Telephone:

Not Mentioned

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