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