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