Description:

The Associate II (A), assists with minimal guidance, the Senior Director of Regulatory Affairs Clinical/ FDA Communications.Assists the Senior Director of Regulatory Affairs/ Clinical Affairs in managing, coordinating, tracking and follow-up on FDA Communications and ANDA status for assigned ANDAs, FDA databases, spreadsheets and communicating to internal stakeholders the daily FDA communications/ updates

Essential Functions:

Assist the Senior Director of Clinical Regulatory Affairs/ FDA Communications in managing, coordinating, tracking and follow-up on FDA Communications and ANDA status for assigned ANDAs Manage, coordinate, submit, track and follow-up on Controlled Correspondences and Meeting Requests that are the responsibility of the CRA Department. Manage and maintain the Master sheet, launch sheet and FDA database. Ensuring that all action items, pending activities and time lines are correct and up to date. Manage and coordinate and submit CRA Department White Paper’s on current projects under development. Track the Food and Drug Administration’s Product-Specific Recommendations for Generic Drug Development website for Bioequivalence Updates for Amneal current products. Disseminate any new information and provide updates and summary on any new changes.

Additional Responsibilities:

Assist in reviewing and ensuring standards for eCTD submissions Manage and maintain the In Vitro Task Force Bi-Weekly Meeting Minutes. Ensuring that all action items, pending activities and time lines are correct and up to date Manage, coordinate, schedule and track Vendor Audits conducted by the CRA ANDA Department within the US and International. Submission/tracking of inter department communications and requests Maintain department databases Assist in developing sections M1, M2.7 and M5 for ANDA submissions, as required