Sr. Director, Clinical Regulatory Affairs

3 weeks ago


Watertown, United States ClinCrowd Full time
  • Minimum 10 years of experience in the biopharmaceutical industry and 5 years of direct experience in a regulatory strategy role required
  • Experience supporting clinical development teams in the autoimmune disease space is a must
  • Provides regulatory guidance and input to project teams
  • Designs and implements regulatory strategies to obtain and maintain clinical trial applications
  • Oversees the creation and submission of all regulatory filings
  • Extensive knowledge of non-clinical and clinical development, regulatory guidelines of FDA, ICH, EMA, EU NCAs, MHRA and other international regulatory agencies
  • Demonstrated track records of successful regulatory meetings, IND or BLA submissions and approvals
  • Experience in Oncology and Immuno-oncology is preferred but not required
  • Arranges for and leads meetings with global health authorities as needed
  • Provides training and mentorship to regulatory staff and other junior staff at the company


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