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Director, Regulatory Affairs
Title:Director, Regulatory Affairs

Director, Regulatory Affairs will assist with the regulatory leadership and management of one of the company’s early stage development programs and will work closely with Clinical, Research & Development, Pharmaceutical Development, Quality and other disciplines to ensure an effective linkage of regulatory strategy, regulatory requirements, and the timely submission and approval of regulatory filings. Title depends on prior experience.  


  • Lead and manage the compilation and submission of new Investigational Drug Applications (INDs) and Clinical Trial Applications (CTAs).
  • Facilitate cross-functional writing of nonclinical reports, IND sections, protocols, etc. supporting regulatory submissions etc., as well as write and edit documents as needed.
  • Assume responsibility for IND maintenance, including routine and more substantial IND amendments.
  • Coordinate and lead communication with the relevant personnel at the FDA.
  • Support the preparation and conduct of Agency meetings as necessary, including preparation and coordination of meeting requests and briefing packages.
  • Support late stage development, including supporting the development of NDA/MAA and other global filing plans.
  • Manage contract staff and vendors as needed to support regulatory activities.
  • Coordinate with Regulatory Operations in the generation of documents suitable for electronic filings


  • Minimum 7-10 years’ experience in Regulatory Affairs in the pharmaceutical/biotech industry.
  • Bachelor’s degree in a scientific discipline, advanced degree preferred. 
  • Experience preparing pre-IND meetings, IND submissions and IND maintenance.
  • Strong attention to detail and the ability to manage multiple tasks.
  • Ability to represent Regulatory Affairs at team meetings and meetings with strategic partners
  • Excellent written and communication skills.
  • RAC certification from the Regulatory Affairs Professionals Society a plus.
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