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 valuable Regulatory CTD modules drafting & review skills.