Manager Regulatory Affairs

Summary

Experience:

10 - 12 Years

Location:

Aurangabad, Mumbai

Education:

UG - B.Pharma - PharmacyPG - M.Pharma - Pharmacy,M.Sc - Chemistry

Industry Type:

Pharma/ Biotech/Clinical Research

Role:

Drug Regulatory Dr.

Functional Area:

Healthcare, Medical, R&D

Desired Candidate Profile

Should have a sound knowledge of process & analytical chemistry should have hands on experience.Should have experience in answering regulatory deficiencies / queries.experience on regulatory requirements of US FDA, COS-EDQM, UK-MHRA, TGA-Australia.

Job Description

1)Preparation and submission of Registration Dossiers.
2)Planning for generation of data in line with global regulatory requirements.
3)Review, Compilation and Submission of dossiers/documents in a scheduled time frame.
Review & scrutiny of data

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Company Profile

Harman Finochem Ltd. is engaged in the manufacture and export of Bulk-drugs/Active Pharmaceutical Ingredients. The Company has three manufacturing sites located in India.

Contact Details

Company Name:

Harman Finochem Ltd

Website:

http://www.harmanfinochem.com

Executive Name:

Kulwinder Singh

Address:

Not Mentioned

Email Address:

careers@harmanfinochem.com

Telephone:

022-67330100

Posted in: Aurangabad,B.Pharmacy,M.Pharmacy,M.Sc,Mumbai,Regulatory Affairs