Executive Regulatory Affairs

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 good Regulatory CTD modules drafting & preliminary review skills.