Amy Robinson

In addition to Regulatory Affairs Specialist responsibilities:

• Serve as RA lead for assigned commercial and investigational programs.
• Collaborate with cross-functional teams to coordinate, compile, and submit IND and NDA submissions.
• Finalize, upload, and perform final review of eCTD filings.
• Manage and mentor a direct report.

• Compiled and submitted Annual Reports and Periodic Adverse Experience Reports.
• Reviewed documentation for submissions to the FDA in a format compliant with FDA standards.
• Assisted with electronic submissions as needed.
• Communicated with stakeholders (internal and external) in order to meet timelines for submissions.

• Compiled and authored Annual Reports.
• Assisted in determining the appropriate regulatory filing strategy for new submissions and post-approval changes.

In addition to Regulatory Affairs Associate responsibilities:

• Reviewed and compiled documentation for submissions to the FDA in a format compliant with FDA standards.
• Independently determined the appropriate regulatory filing strategy for new submissions and post-approval changes.
• Communicated with FDA as necessary.

• Reviewed and compiled documentation for submissions to the FDA in a format compliant with FDA standards.
• Assisted in determining the appropriate regulatory filing strategy for new submissions and post approval changes.
• Filed all Agency correspondence into the regulatory filing system.
• Compiled and authored Annual Reports and Periodic Adverse Experience Reports.
• Assisted in the development of templates for electronic submissions.

• Received and evaluated product complaint reports.
• Coordinated investigative activities and documented findings, conclusions, and corrective actions in the Trackwise system.
• Authored Annual Quality Reviews.
• Reviewed, assessed and dispositioned changed requests and revised master documentation.
• Collaborated with Regulatory Affairs in writing sections of electronic submissions.

• Assisted Pharmaceutical Product Manager (PPM) in the preparation of CMC documentation (specifications, methods, MBRs, PBRs).
• Provided technical support in the creation of Annual Quality Reviews and Annual Reports.
• Assisted PPM as liaison for internal and external contacts.

• Assembled documents for submissions and annual reports.
• Maintained the Regulatory Affairs records room.
• Obtained Drug Master File letters from manufacturers.