Glenmark Pharmaceuticals Ltd Mumbai Job Opening For Manager Regulatory Affairs- CMC

Glenmark Pharmaceuticals Ltd Mumbai Job Opening For Manager Regulatory Affairs- CMC

Education

B.Pharma in Any Specialization

M.Pharma in Any Specialization

Experience: 7 - 12 Years

Designation: Manager Regulatory Affairs- CMC

Work Location: Mumbai

Salary: ₹ 12,00,000 - 14,00,000 P.A

Job Description

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