Valuable knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines.
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 caseswith respect to ICH quality / post approval USFDA guidance and aware for Post approval submission guidelineand procedure for Annual report/CBE 0/CBE 30 and PAS filling
Drafting of the Annual Reportwith required submission data as per USFDA guidance.
Preliminary reviewof entire submission package.
Awareness about the FDA recommendation on the commercial marketing status notificationsubmission 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 positive Regulatory CTD modules drafting & preliminary review skills.
Education:
B. Pharm B. Pharm - Required
M. Pharm M. Pharm - Preferred