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Manager / Sr. Manager Regulatory Affairs

By: JobSearch | Views: 809 | Date: 25-Jun-2013

Manager / Sr. Manager Regulatory Affairs by Harman Finochem Ltd in Mumbai, Mumbai Suburbs,Experience: 10 to 20 yrs.Job Description:Preparing , Filing & Life-cycle management of dossiers,Having correspondence with regulatory agencies for filing and responding to the agencies queries,Responding to the customers queries, deficiency letters, ect.e-CTD filing with US & EU market & their life cycle management.Education:(UG - B.Sc - Chemistry, B.Pharma - Pharmacy) OR (PG - M.Pharma - Pharmacy, M.Sc - Chemistry) OR

Manager / Sr. Manager Regulatory Affairs

by Harman Finochem Ltd in Mumbai, Mumbai Suburbs
Experience: 10 to 20 yrs.Posted on: 24 Jun

Job Description

Preparing , Filing & Life-cycle management of dossiers
Having correspondence with regulatory agencies for filing and responding to the agencies queries
Responding to the customers queries, deficiency letters, ect.
e-CTD filing with US & EU market & their life cycle management.
Making SOP on e-CTD submission 
Review of Specifications, Analytical methods , validation documents & technical development records
CCF formalities (Specification/STPs/BPRs)
Periodic internal audit of QA /QC documents
Providing training to Marketing and RA personnel 
Salary:

Not Disclosed by Recruiter

Industry:

Chemicals / PetroChemical / Plastic / Rubber

Functional Area:

Production, Manufacturing, Maintenance

Role Category:

Senior Management

Role:

Head/VP/GM-Regulatory Affairs

Keyskills:

Regulatory affairs, cmc documentation, ctd, ra, dmf

Desired Candidate Profile

Education:

(UG - B.Sc - Chemistry, B.Pharma - Pharmacy) OR (PG - M.Pharma - Pharmacy, M.Sc - Chemistry) OR ( Doctorate - Ph.D - Advertising/Mass Communication)

Please refer to the Job description above

Company Profile

Harman Finochem Ltd 
http://www.harmanfinochem.com
Harman Finochem Limited is a professionally managed independent company engaged in manufacturing of Active Pharmaceutical ingredients (API's) and chemical intermediates. 

The company was established way back in 1983 by Bhupinder Singh Manhas, the CMD of the company.

Manufacture and Exporter of Active Pharmaceutical ingredients.
Two manufacturing sites at Aurangabad and one at Vapi with capacity of 350,000 Litres.
Supply of API"s as a Major Thrust Area to pharma and generic companies.
Certificate of recognition as 'EXPORT HOUSE' by Government of India.
State-of-the art manufacturing facilities inspected & complying with cGMP norms as per USFDA, ICH Q7A, TGA, PIC, WHO-GMP, Schedule M and Japanese Foreign Accreditation.
State-of-the-art Quality Control Laboratories with GLP compliance.
cGMP compliance Pilot plant with clean room facility.
Powder processing area with pneumatic controls and Particle Size options: Milling & Micronising.
CRAMs offered.
State-of-the-art R & D center coming up 4th quarter 2013 in Navi-Mumbai.

Contact Details
Recruiter Name:

Mr. Kulwinder Singh

Contact Company:

Harman Finochem Ltd

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