Required IRA Officer - Finished Formulation

2 - 5 years

2 - 3 Lacs

Posted:1 week ago| Platform: Naukri logo

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Job Type

Full Time

Job Description


Company Name : Exemed Pharmaceuticals ( Formulation Business )

Designation: IRA Officer/Sr.Officer

Location : Vadodara (Corporate Office)

Role & responsibilities

  1. In-depth Knowledge of Liasoning activities i.e. Test licence, Export NOC, CT, PP

    , CoPP,

    FSC, Import permit applications
  2. Communicate with internal team and Cross-functional team for Liasoning activities and prepare documents for submission
  3. Communicate and visit to FDA for all Liasoning related activities
  4. Clarifying country-specific regulatory Liasoning requirements.
  5. Communicating with internal team/embassies for attestation/legalization/apostillation.
  6. Prepare, review, compile and submit regulatory dossiers (CTD/ACTD/Country specific format).
  7. Maintain updated regulatory files and technical documents.
  8. Respond to regulator queries within timeframe.

If intereted pls share updated resume on recruitment@exemedpharma.com

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