Amneal Pharmaceuticals logo

Senior Regulatory Affairs Specialist

0 years

0 Lacs

Ahmedabad Gujarat India

Posted:1 week ago| Platform: Foundit logo

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Skills Required

post-approval procedures solid oral dosage form api dmf review topical-inhalation dosage form regulatory submission plan regulatory aspects cbe 30 usfda guidelines sterile dosage form post approval submission guideline complex dosage form anda submission activities manufacturing process submission data annual report cbe 0 regulatory ctd modules drafting

Work Mode

On-site

Job Type

Full Time

Job Description

  • Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines.
  • API DMF review with respect to USFDA regulatory requirement.
  • Exposure of the Solid oral dosage form /

    Sterile dosage form / complex dosage form

    / topical-Inhalation dosage form and brief manufacturing process and key regulatory aspects.
  • Ability to

    preliminary review the change cases

    with respect to ICH quality / post approval USFDA guidance and aware for

    Post approval submission guideline

    and procedure for Annual report/CBE 0/CBE 30 and PAS filling
  • Drafting of the

    Annual Report

    with required submission data as per USFDA guidance.

  • Preliminary review

    of entire submission package.
  • Drafting the

    controlled correspondence/Briefing Package

    to FDA on specific cases as needed for assigned projects.
  • Awareness about the FDA recommendation on the commercial

    marketing status notification

    submission in terms of content and time frames.
  • Coordination with Cross Functional teams for the documents availability as per regulatory submission plan.
  • Ensure the no delay in drafting and compiling the regulatory submission.
  • Maintain regulatory information as per allocated task.
  • Having good Regulatory CTD modules drafting & preliminary review skills.

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