Description

Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines.

Exposure of the Sterile dosage form / complex injectable dosage form and brief manufacturing process and key regulatory aspects.

Ability to preliminary 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 Drafting of the Annual Report with required submission data as per USFDA guidance.

Preliminary review of entire 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 & preliminary review skills.

📌 Executive, Regulatory Affairs (Ahmedabad)
🏢 Amneal
📍 Ahmedabad