Assistant Manager, Regulatory Affairs

Amneal Pharmaceuticals · Ahmedabad

Good knowledge of US ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines.
Exposure of the Solid oral dosage form/Liquid Oral/Transdermal dosage form / topical-Inhalation dosage form and brief manufacturing process and key regulatory aspects.
Ability to 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
Preparation and submission of controlled correspondence
Review and compilation of Annual Report with required submission data as per USFDA guidance.
Review and compilation of entire supplement/amendment submission package.
Awareness about the FDA recommendation on the commercial marketing status notification submission in terms of content and time frames and submissions.
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 & review skills.

Assistant Manager for role of taking up the allocated post approval regulatory submissions for Oral solid/Oral Liquid/Transdermal/Topical/Inhalation dosage forms.

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