Assistant/Deputy Manager-Regulatory Affairs(US Mkt-Formulations)

7 - 9 years

0 Lacs

Posted:3 days ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Dear All,

Regulatory Affairs Assistant Manager/Deputy Manager

Key Responsibilities:

  • Defining Regulatory strategies for submission for US market
  • Review of team who are responsible for preparation and compilation of the dossiers in CTD/eCTD and other formats as required for submission to different regulatory authorities.
  • Review of dossiers in CTD/eCTD for US market.
  • Review & approval of Batch Records, Specifications and STP etc.
  • Responding to queries /deficiencies received from regulatory authorities.
  • Monitoring of timely submission of Labeling Initials, Amendments, Labeling Supplements and Annual Reports.
  • Responsible for life-cycle management of regulatory submissions.
  • Responsible for preparation and maintenance of all the documents related to the regulatory submissions.
  • Coordinate and supports all concerned departments with respect to the required documents for submission purpose.
  • Training the line function in updating the current guidelines and requirements.

Note:

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