Glenmark is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity) with eight molecules in various stages of clinical development. The company has a significant presence in branded generics markets across emerging economies including India. Its subsidiary, Glenmark Generics Limited has a fast growing and robust US generics business.
Post : Officer - Regulatory Affairs
Profile Summary
Support in ANDA dossier compilation and regulatory database management
Roles & Responsibilities
Compilation of ANDA dossier in eCTD format. Review of Technical data required for ANDA compilation and submission. Thorough DMF review IIG Assessment of assigned products Drafting of Controlled correspondence to the USFDA. Support different stake holders for OSD and Oral liquid dosage forms by providing regulatory strategics. Timely submission of assigned ANDAs. Minimum errors in dossier compilation and review and thereby ensure no critical regulatory gaps in the compiled modules and reviewed documents. Good turn¬around time for assigned tasks and support required by R&D.
SKILLS
Complete understanding of ICH guidelines and FDA guidance. Understanding of Analytical Method Validation requirements and parameters included/stability/Photo stability and Forced degradation, etc. Knowledge w.r.t. OSD/Liquid Oral dosage forms.
Additional Information
Experience : 02-03 years
Qualification : M.Pharm, B.Pharm
Location : R&D Centre, Taloja
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 28th February, 2021
Interested candidate can share their resume at Simran.Gill@glenmarkpharma.com
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