Glenmark was founded with a vision to emerge as a leading integrated research-based, global pharmaceutical company. Our branded generics business has a significant presence in markets across emerging economies including India. The generics business services the requirements of developed markets like US and Western Europe. Our API business sells products in over 65 countries including the US, various countries in the EU, South America and India.
Post : Assistant Manager - Regulatory Affairs
This role is part of US Market, persona will be responsible for ANDA dossier compilation & deficiency response Management
Roles & Responsibilities
Compilation of ANDA dossier, deficiency response to FDA quenes in eCTD format Strong review of Technical data required for ANDA compilation and deficiency response submission, Thorough DMF review & complete understanding of ICH guidelines and FDA guidance’s Strong understanding of CMC. formulation development. Analytical Method Validation requirements and parameters included/stability/Photo stability and Forced degradation, etc Knowledge w r t OSD/Liquid Oral/Derma dosage forms is essential for this position Drafting of Controlled correspondence to the USFDA Support different stake holders for OSD, Oral liquid dosage forms and Derma by providing regulatory strategies Impart training to CFT's for current FDA regulations and expectations w r t data requirement
Timely submission of adequate and accurate ANDAs in the US market in eCTD format To ensure quick turnaround time for replying to agency's deficiency letters (i e IR. CR. ECD etc ) from FDA divisions like OPQ. Microbiology, Labeling. Bio- equivalence Support different stake holders for all unapproved under review and new under development products for dosage forms like OSD. Liquid Orals, and Derma by providing regulatory strategies Support for labeling review and submissions
Experience : 08 to 9 years
Qualification : M.Pharm / B.Pharm
Location : R&D Centre, Taloja, Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 15th July, 2021
Interested candidate can apply on Simran.Gill@glenmarkpharma.com along with updated resume.
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