Responsible for leading regulatory strategy, and coordinating regulatory projects, plans and schedules with PDT/GPT project team members and partners for submission of Investigational New Drug Applications and Biologic License Applications for oncology biological products.  Responsible for preparing, implementing, and coordinating regulatory submission to FDA and world wide agencies.

-Lead innovative regulatory strategy development for all phases of drug development for biological investigational products
 -Represents Regulatory Affairs and provide guidance to Research, Development, and Clinical at PDT/GPT Project Team meetings. Assuring the RA CMC lead is informed and involved as needed.
-Lead PDT sub team meetings
- Interacts with responsible departments and manages collection, review, and assembling of the scientific (preclinical, clinical, and CMC) and administrative sections of submissions to regulatory agencies.
- Submits regulatory information to FDA and world-wide regulatory agencies including, but not limited to, INDs, BLAs, preclinical and clinical protocols and amendments, and adverse experience reports.
- Plan, coordinate, prepare and execute meetings and teleconferences with regulatory agencies.
- Prepares, manages, and coordinates clinical trial applications and clinical trial labeling with world-wide Contract Research Organizations and Consultants.
- Reviews and determines the applicability of supporting documentation for inclusion in regulatory submission.
- Reviews all supporting documentation required in regulatory applications for accuracy and completeness.
- Monitors product related corporate activities for regulatory compliance, including all preclinical and clinical plans and practices.
- Leads regulatory review and regulatory strategy development for Due Diligence activities.
- Interact with Company Partners and Consultants for various regulatory matters as needed

Must be action oriented, have customer focus, comfort around higher management, ability to motivate teams, manage vision and purpose, and have excellent time management and organizing skills     
 

Position Requirements   Position:
6 years experience in Regulatory Affairs. Preferably also at least 8 years experience in the Biopharmaceutical Industry. Knowledge of FDA regulations required. Regulatory experience in biological products required. Direct liaison experience with FDA required. Knowledge of international regulatory guidelines and GCP and GMP knowledge is required.
 
Education:
MD or MS, Ph.D, in a scientific discipline.