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Senior Associate / Assistant @ NMS Consultant

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 Senior Associate / Assistant

Job Description

  • End to end exposure w.r.t. review/reg.strategy right from development through optimisation, tech transfer, EB Batches, filing of ANDA/NDA of sterile Injectable not limited to conventional SI, preferably inclusive of complex SI (i.e. Peptides, PFS, Bags, Long Acting Injectables, and Liposome Injectables etc).
  • Added advantage to the candidates who have prior handsome exposure to Drug Device combination products/Human Factor studies etc.
  • Review independently each technical documents of SI in compliance to respective US FDA regulatory/ICH/Compendia GP etc requirements.
  • Participation in Cross Functional Team Internal/External and contributing towards the progress of the projects accomplishment.
  • Should have proactive planning and organisation skill in preparing/drafting the requisite correspondence(s) (i.e. CC, Meeting requests etc ) to US FDA in time so as to avoid any delay on the assigned projectss progress.
  • Should have handsome experience in eCTD w.r.t. compilation of new ANDA/NDA and the respective Life cycle management (LCM) submissions.

Employement Category:

Employement Type: Full time
Industry: Pharma / Biotech
Role Category: Corporate Legal Department
Functional Area: Not Applicable
Role/Responsibilies: Senior Associate / Assistant

Contact Details:

Company: NMS Consultant Hiring
Location(s): Mumbai

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