Regulatory Affairs Clinical FDA Associate II (Biotech)

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

 

Education:

• Bachelors Degree (BA/BS) Science - Required

Experience:

• 2 years or more in Pharmaceuticals Regulatory

Skills:

• Strong written and verbal communication skills - Intermediate
• Team player, able to collaborate cross-functionally across levels and countries - Intermediate
• Strong time management, organizational, and planning skills - Intermediate
• Ability to multi-task, and to adjust priorities as needed. - Intermediate
• Ability to work independently with a minimum of supervision - Intermediate
• Strong problem solving skills and analytical ability - Intermediate

Specialized Knowledge:

• Experience in MS Word, Excel, Outlook, Powerpoint, and Adobe Acrobat

Licenses:

• RAC-1 1/2 Yrs-Preferred

 

Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.