Glenmark Pharmaceuticals Ltd – Openings for Regulatory Affairs
Manager Regulatory Affairs- CMC @ Glenmark Pharmaceuticals Ltd
Experience: 7-12 yrs
Qualification: B.Pharm / M.Pharm
Roles and Responsibilities:
- Compilation of ANDA dossier, deficiency response to FDA queries 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.
- 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 CFTs for current FDA regulations and expectations w.r.t data requirement.
Key Expectations and Deliverables:
- Timely submission of adequate and accurate ANDAs in the US market in eCTD format.
- To ensure quick turnaround time for replying to agencys 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.
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