Openings for Regulatory Affairs - CMC @ Glenmark Pharmaceuticals Ltd

 

Manager Regulatory Affairs- CMC @ Glenmark Pharmaceuticals Ltd

Experience: 7-12 yrs

Location: Mumbai

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.

If the above job description matches with your profile then please email your CV at varun.jain@glenmarkpharma.com