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Sr. Director/Vice President, Regulatory Strategy

Remote, NY

Posted: 07/12/2024 Employment Type: Contract Job Category: Regulatory Job Number: 3870

Job Description

Reporting to the President & CEO, the successful candidate will be responsible for leading and advising regulatory staff on regulatory strategies and compliance activities for development programs, as well as future commercial activities. 

Responsibilities:
  • Management oversight of regulatory activities for assigned programs 
  • Assume lead role in developing and guiding regulatory strategies to support successful development programs and regulatory approvals 
  • Oversee the preparation of global regulatory development plans (RDPs) outlining strategic plans to achieve rapid gene therapy product development
  • Ensure that all projects have a clearly defined regulatory pathway and milestones leading to successful filings and approvals
  • Oversee the development and management of defining key regulatory timelines and regulatory critical path activities
  • Supervise and provide guidance for all global health authority communications/ submissions 
  • Provide primary regulatory review of applications and ensure that sections are well written, timely submitted and in compliance with internal and external standards
  • Establish processes with Commercial and Legal to support reviews of promotional material and labeling activities to support future commercial products
  • Communicate effectively with the senior management personnel (and external partners, where appropriate) 

Requirements/Qualifications:
  • BS or BA in a scientific discipline and/or equivalent experience; Advanced degree strongly desired with at least 10 years in Regulatory Affairs in the industry
  • Must have experience in cell and gene therapy drug development
  • Experience in preparing regulatory strategies (e.g., regulatory development plans), highlighting precedence, evaluation of special regulatory procedures, and risk/mitigation assessments
  • Previous experience in a senior regulatory role, including interactions with regulatory agencies (as lead regulatory representative) is desirable
  • In-depth understanding of regulations and guidelines governing all phases of drug development (for both drugs and biologics)
  • Excellent verbal and written communication skills including presentation skills
  • Experience with electronic submission process desirable
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