Head of Regulatory – Gene Therapy -NJ/Boston/San Francisco

RESPONSIBILITIES:

Reporting to the Chief Development Officer the successful candidate will:

  • Act as the regulatory lead on specific program(s) and represent the regulatory function on related cross-functional program teams
  • Participate in definition and implement regulatory strategy for path to approval
  • Plan, prepare, and review submissions to regulatory authorities (including FDA, EMA and other national authorities) to support the conduct of clinical trials and approval of marketing applications (IND, CTA, BLA, MAA)
  • Lead regulatory activities for assigned projects in line with US, European, ICH, and other applicable requirements to ensure compliance
  • Manage the regulatory aspects of products and projects including achievement of timelines and deliverables
  • Ensure that regulatory documents are accurate, complete and verifiable, and confirm compliance with regulatory requirements
  • Be the primary liaison with regulatory authorities for the specific programs he/she is leading
  • Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings, and interface with regulatory authorities
  • Coordinate and prepare responses to questions, requests for information from regulatory authorities
  • Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs
  • Train and mentor other regulatory affairs personnel
  • Other activities as may be assigned

To apply please email resume and cover letter jobs@tseworldwide.com

Author: TSEWORLDWIDE

Michael is a 1996 graduate from Rutgers, The State University of NJ where he majored in Political Science. After Rutgers, Michael spent a year in Israel studying and working with early stage tech companies. After returning to the US, Michael spent 5 years with The Princeton Review in Operations of their graduate level courses. In 2001, Michael joined a staffing company where he led his office in sales of IT consulting services. In 2003, Michael started TSE and quickly found a niche in Strategy Consulting. He has formed partnerships with some of the leading consultancies in the areas of portfolio strategy, commercial assessment, market assess, payer strategy and operational effectiveness. Michael has helped consultancies and client side companies make key hires. In addition to recruiting, Michael helped Rutgers University create their Center for Innovative Ventures of Emerging Technologies and served as an Entrepreneur-in-Residence and Sounding Board Member for 5 years. He continues to stay active in the field of higher learning helping students of the sciences think about careers in the pharmaceutical industry.