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Head of Regulatory Affairs (Oncology)

Details

  • Location San Diego, California
  • Job Type Direct
  • Pay $175,000.00
  • Category A&F
  • Date Posted Oct 12, 2017

Overview

About the Company

Our client, a clinical-stage biotechnology company developing unique oncologic drugs treatments, is currently seeking a Head of Regulatory Affairs to join their rapidly growing team. The Regulatory Affairs head will be a key leader of the management team and will support the development and implementation of regulatory strategies and processes to secure worldwide product approvals.

Responsibilities

  • Leading the integration of Regulatory Affairs across all the operative functions related with clinical development, CMC, devices, quality assurance and future product commercial launch initiatives.
  • Clinical trial design including trial design for accelerated approvals
  • Pharmacovigilance and drug safety compliance
  • Regulatory submissions and discussions with the FDA, EMA and PMDA
  • CMC/cGMP of biologics to support pivotal studies and commercial launch, device regulatory compliance for world-wide use
  • Commercial launch and product promotional activities.
  • Serving as point of contact and represent the Company before regulatory authorities, including preparation of meeting agendas, materials, and minutes.
  • Managing and overseeing all operational aspects of regulatory submissions
  • Providing counsel, training, and interpretation of FDA and other regulatory agencies to Company personnel

Qualifications

  • Minimum of 10 years of regulatory experience in US/OUS (EU/Japan) related with pharmaceutical/device development and commercialization
  • Experience in oncology programs and accelerated approvals
  • B.S. / M.S. degree or higher in a life science field is minimum. Ph.D. or equivalent is highly desired. RAC accreditation is desirable
  • Experience in interfacing with the FDA, EMA and PDMA
  • Experienced in cGMP of biologics
  • Extensive knowledge of US FDA/EMA drug/device development process, regulations and guidelines
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