Regulatory Affairs Associate I

1 - 3 years

6 Lacs

Posted:1 week ago| Platform: Naukri logo

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Work Mode

Work from Office

Job Type

Full Time

Job Description

How you ll spend your day
    • Work with other members of staff for reporting EU Gx & Specialties metrics.
    • Responsible for Metrics and Reporting mainly for EU, but ad hoc Globally and for supporting GRA Compliance
    • Provide ad hoc global or regional reports, as required
    • GRIDS data entry
    • Retrieval and analysis of data from GRIDS
    • Retrieval and analysis of data from Teva RA systems
    • Assist with managing GRA s procedures and learning systems for SOPs & Work Instructions, including processing through established DMS and LMS and monitoring of periodic reviews.
    • The candidate will be expected to work within GRA, liaising with other business units (eg R&D, portfolio, RA etc) to ensure that all data is compliant.
    • They need to be familiar with the IT systems the company uses in order to retrieve the data efficiently and accurately.
Your experience and qualifications
  • Required: Bachelor s or Master s degree in Life Sciences or Information Technology.
  • Preferred: MS in scientific or information technology discipline.
  • Required: 1-3 years (Preferred experience in regulatory operations / affairs / Pharmaceuticals / biotechnology / medical device industry).
  • Significant experience in data management and handling large amounts of data
  • Significant experience in use of databases and retrieving information

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