Glenmark Pharmaceuticals – Hiring Manger – Regulatory Affiars (CMC)

Glenmark Pharmaceuticals - Hiring Manger - Regulatory Affiars (CMC)

Job openings @ Glenmark Pharmaceuticals

Post Name: Manger – Regulatory Affiars (CMC)
Qualification: B.Pharm/ M.Pharm
Experience: 7 – 12 Years
Openings: 1 Vacancy
Location: Mumbai
Salary: ₹ 12,00,000 – 14,00,000 P.A
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 [email protected]

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