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
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
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
Executive Name: Mr. Akhil Jain / Mr. Jastin