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Executive, Regulatory Affairs

Amneal IndiaAhmedabad🇮🇳India

Quick overview

SeniorityMid Senior
Employment typeFull Time
Work modeHybrid
LocationAhmedabad, India

Job description

  • Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines.
  • API DMF and DMF Change Notification 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.
Education:
  • B. Pharm B. Pharm - Required
  • M. Pharm M. Pharm - Preferred
Experience:
  • 5 years or more in 5 - 8 Years
Specialized Knowledge: Licenses:

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