Executive, Regulatory Affairs

• Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines.
• API DMF and DMF Change Notification review with respect to USFDA regulatory requirement.
• 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 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.
• Drafting the controlled correspondence/Briefing Package to FDA on specific cases as needed for assigned projects.
• Awareness about the FDA recommendation on the commercial marketing status notification submission in terms of content and time frames.
• 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.

Education

• B. Pharm B. Pharm - Required
• M. Pharm M. Pharm - Preferred

Experience

• 5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses