Executive/Sr. Executive-Regulatory Affairs

2 - 6 years

4 - 8 Lacs

Posted:19 hours ago| Platform: Naukri logo

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Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

  • Preparation of country specific certificate of pharmaceutical product (COPP), Product

permission, Shelf-life extension, Additional pack size, Test license, Free sale certificate (FSC),

Marketing manufacturing certificate (MMC), Approval of mfg. & analytical chemist.

  • Review and sign of Shade Card as per country specific.
  • Review and sign of Packing Material Specification.
  • Review and sign of Raw Material Specification.
  • Review and sign of In Process Specification.
  • Review of Stability protocols.
  • Sign all documents related to FDA work.
  • Sign in Vendor addition/changes documents
  • Review of regulatory documents requested by concern department.
  • Compliance of TI sheet.
  • Regulatory documentation support for filling dossier.
  • Participate in Self inspection of QA & QC as an auditor from RA Team.
  • Review of other compliance documents as when required. Other Responsibilities • Arrangement of FG samples, WS, impurities & placebo as per country requirements on request of RA (Corporate office). • Follow-up for Samples from Control Sample. • Review and sign of Process Validation Protocol. • Any other technical work assigned by Seniors

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