• Positive 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.
Qualifications
Education:• B. Pharm B. Pharm - Required