Sun Pharmaceutical Industries Ltd recruitment 2019-Apply online: Sun Pharmaceutical Industries Ltd is inviting eligible candidates to apply online for the position of Research Manager – Pharmaceutical Regulatory Affairs (api) . Candidates can find their eligibility from below details .Eligible and interested candidates can apply from the source may provided at the bottom of this article. This content to be used only for informational purpose and not responsible for the inaccuracy or deficiency of the provided information.
Qualification:PG:MS/M.Sc(Science) – Any Specialization, Chemistry
Post Name: Research Manager – Pharmaceutical Regulatory Affairs (api)
Job Description:- Compilation and review of Drug Master Files, Registration Dossiers & Technical Data Packages/Open Parts for In-House developed APIs and ensuring their updation – Preparation and review of Regulatory Amendments / Variations for smooth API supplies – Preparation of responses to regulatory deficiencies. – Regulatory support to Chemical Research Department, Analytical Department, Chemical manufacturing, Quality Assurance and Regulatory Affairs-Pharma – Review of TDPs of outsourced intermediates for regulatory adequacy – Ensure reposition of regulatory database and compliance to departmental guidelines. Job Profile: – To review quality and manufacturing end data for various in-house developed APIs for regulatory adequacy for compilation of Drug Master Files/Registration Dossiers, Amendments/Variations, Technical Data Package/Open Parts of DMFs for In-House developed APIs and their updation to meet current regulatory requirements. – To coordinate with Chemical Research Department, Analytical Department, Manufacturing locations and procurement team in generating data as per the requirements of regulatory agencies. – To ensure reposition of API dossiers into central repository and to provide information about regulatory commitments in timely manner.
Salary: Not Disclosed by Recruiter
Opening Date: 06-05-2019
About Company :Sun Pharma an international,specialty pharmaceutical company headquartered in India with a global manufacturing network across 25 countries.