Fast-Track is seeking a Director of Regulatory Affairs who has experience in drug and biologic clinical development and regulatory strategic planning and strong writing skills for the development of regulatory documents including preIND, IND, and NDA/BLA for US FDA submissions. The individual we are seeking must be able to leverage their regulatory and clinical knowledge and experience to ultimately contribute to the growth and success of Fast-Track Drugs & Biologics, LLC and the successful licensure of important drugs and biologics.

Key Duties and Responsibilities

• Manage and interface with Clients on strategic planning on all phases of drug or biologic development from nonclinical development to support IND and clinical development from Phase 1 through Phase 4 projects.
• Act as sponsor’s authorized representative for interactions and submissions to the FDA.
• Keep up with emerging regulatory requirements for drug development and post marketing requirements.
• Establish and manage projects against timelines.
• Working with our regulatory affairs staff, develop or review regulatory submissions.
• Write/review clinical protocols and clinical development plans.
• Write regulatory documents (eCTD formatting) including sections of IND, IDEs, NDAs, and BLAs, and ensure that the information is in compliance with the applicable regulatory requirements.
• Write clinical trial final reports.
• Working with the COO and the Director of Clinical Trial Operations identify appropriate investigators for clinical trials and review clinical trial documents.
• Working with President and COO, develop project cost proposals for clients.
• Work with the sponsor to select appropriate members of a Data and Safety Monitoring Board.
• Work with study statistician(s) on clinical trial Statistical Analysis Plans
• Identify SOPs to be developed for the Department’s operation, and assign responsibility for preparation, review and approval of the SOPs and staff training on SOPs.
• Comply with the United States Code of Federal Regulations (CFR) (when applicable) and operate under the guidance of The International Conference on Harmonisation of Technical Requirement for Registration of Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP) Guidelines.

Desired Education, Skills and Experience

• Ph.D. or M.D. degree in scientific or health care field
• A minimum of 8 years experience with drug and/or biologic product development
• Experience in a strategic leadership capacity
• Must demonstrate understanding of drug development and knowledge of FDA requirements
• Direct experience with FDA required and international experience preferred
• Highly organized with attention to detail.
• Strong verbal and written communication skills are required, as well as excellent scientific writing, presentation and documentation skills.
• Familiarity with MS Word, MS Excel, Adobe Acrobat and PowerPoint applications.
• Exceptional self-management ability
• Travel as needed to clinical sites both domestic and internationally and to meetings at FDA