Manager / Sr. Manager Regulatory Affairs Information

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Harman Finochem Ltd

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. ... Read More

Address	107-AVinay Bhavya Complex 159-A, C.S.T.Road, Kalina, Santa Cruz (East), Mumbai India
Website	www.harmanfinochem.com
Holding	No Holding Details

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Manager / Sr. Manager Regulatory Affairs

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