HAB Pharmaceuticals & Research Ltd - Walk-In Interview for Executives - DRA on 23rd & 24th Nov' 2018
Walk-In Interview for Drug Regulatory Affairs Executive
Date & Time: 23rd November - 24th November, 9 AM onwards
Venue:
HAB Pharmaceuticals and Research ltd
308, TV Industrial Estate SK Ahire marg
Behind Glaxo Lab,
Worli Mumbai 400015
Experience: 2 – 4 yrs
Job Description:
1- Obtaining appropriate regulatory compliance of pharmaceutical products by preparation of documents for obtaining requisite approvals.
2- Be responsible to obtain No Objection certificates (NOCs), Manufacturing Licenses and other certifications for all new products from SLAs, Zonal and central Drug Control Authorities.
3- Liaising and negotiating with regulatory authorities and Preparation of Common Technical Documents (CTD).
4- Preparation of Dossiers for Product Registrations with State Food and Drug Administration (FDA) and Central Drug Standard Control Organization (CDSCO) and ROW submissions.
5-Responsible to coordinate with cross functional teams, customers for Vendor questioners, Technical Agreements, Quality Agreements, Sponsor requirement agreements and declarations.
6- Maintain the registration certification records of registered products for renewal of registration.
7-Planning of Export shipments and coordinate with CMOs, Quality, Dispatch and supply chain management.
8-Keep knowledge up to date with regards to regulatory guidelines and requirements as well as for new technical trends.
9-Knowledge/Review of technical documents like DSS, FPS, Validations and Stability Data etc. is an added advantage.
2- Be responsible to obtain No Objection certificates (NOCs), Manufacturing Licenses and other certifications for all new products from SLAs, Zonal and central Drug Control Authorities.
3- Liaising and negotiating with regulatory authorities and Preparation of Common Technical Documents (CTD).
4- Preparation of Dossiers for Product Registrations with State Food and Drug Administration (FDA) and Central Drug Standard Control Organization (CDSCO) and ROW submissions.
5-Responsible to coordinate with cross functional teams, customers for Vendor questioners, Technical Agreements, Quality Agreements, Sponsor requirement agreements and declarations.
6- Maintain the registration certification records of registered products for renewal of registration.
7-Planning of Export shipments and coordinate with CMOs, Quality, Dispatch and supply chain management.
8-Keep knowledge up to date with regards to regulatory guidelines and requirements as well as for new technical trends.
9-Knowledge/Review of technical documents like DSS, FPS, Validations and Stability Data etc. is an added advantage.
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