* Valuable 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.