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jobs:Executive DRA in Noida

jobs:Executive DRA in Noida

Position Title Executive DRA in Noida
Categories Pharma/Biotech/Clinical Research
Salary 10k-20k
Job New New
Position Summery Designation : Executive DRA Qualification : B.Pharma, B.sc, any Pharma Exprienece : 1 – 2 Yrs Salary : 10k -20k Location : Noida Skills: Dossier Prepration for export
Start Date 2016-01-20
Location Noida
Job Information

Designation : Executive DRA

Qualification : B.Pharma, B.sc, any Pharma

Experience : 1 – 2 Yrs

Salary : 10k -20k

Location : Noida

Skills: Dossier Preparation for export

Job Role & Responsibilities :

  • Dossier Preparation for Export
  • Hands on Preparation, Review and submission of Technical  documents/Dossiers (CTD/eCTD) related to Regulatory affairs for third country Export of Pharmaceuticals Formulations.
  • Preparation and Review of SOPs.
  • Compilation of Validation Protocols/Reports.
  • Hands on experience on Preparation and submission of dossiers as per the country specific guidelines for various countries.
  • Hands on experience on Preparation, review and submission of response to queries from various agencies of various countries Coordinating with cross-functional departments (FR&D, AR&D, QA, QC and production) for documents required for submission of dossiers and responding queries.
  • Preparation and filing of Re-registration of products at various countries according to the authorization validity period.

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