Officer/Executive - Regulatory Affairs

2 weeks ago

Mumbai, India NMS Consultant Full time

Role & responsibilities

  • Responsible for activities related to US/EU market.
  • Prepare the registration dossiers as per regulatory guidelines.
  • Submitting GCC dossiers, variations, and query responses through eCTD software.
  • Ensure timely preparation of the agency's query responses to expedite approvals.
  • Prepare and submit post-registration variations application,  Involved in the renewal process of drug registration.
  • Review technical documents on receipt from various departments before inclusion in various applications  and dossiers.
  • Maintenance of the regulatory database for the US market.
  • Product Lifecycle Management .
  • Discuss and coordinate with cross-functional teams like QA, QC, R&D, Analytical, marketing,
  • manufacturing plant, administrative dept., etc. for finalization of documents and with API vendor for getting  DMF, LOA, CEP, and other API-related documents .
  • Responsible for getting the FDA-approved documents legalized such as Notary, Chamber, Apostille,  Embassy, etc.
  • Responsible for sending the hard copies of documents, samples, columns, impurities, placebo, etc. to respective countries of evaluation
  • Being updated with relevant regulatory guidelines.

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