Istari Oncology seeks a Director, Regulatory Affairs for immediate hire in our Durham, NC offices. The selected individual will be responsible for supporting the day-to-day management of regulatory operations and regulatory compliance activities in accordance with corporate policies, industry standards, and applicable regulatory requirements.
Duties and Responsibilities:
Responsible for managing the regulatory operations activities for company programs
Collaborates with Head of Regulatory Affairs and other company stakeholders to provide input on the development and implementation of the regulatory strategy for all company programs
Oversee IND maintenance activities, including tracking, document development, publishing, and submission activities for company programs
Assess and monitor company regulatory compliance with SOPs, study protocols, industry standards, and regulatory requirements
Manage external vendors to support regulatory operations activities, as needed
Assist QA and other staff with regulatory agency inspections and audit activities, as needed
Provide training and support to cross-functional team members, as needed
Performs other duties as requested
Bachelor’s degree with a minimum of 5 years of Regulatory Affairs experience required (advanced degree in Life Sciences and/or Regulatory Affairs Certification is a plus)
Strong knowledge of US FDA regulations, ICH guidelines, and GXPs and their application to regulatory submissions (global regulatory experience is a plus)
IND submissions management experience required
Excellent organizational and communication skills with an ability to work independently and as a member of a multidisciplinary team
Strong proficiency with Microsoft Office products (Excel, Word, PowerPoint, Outlook, etc.)
Experience with publishing software for regulatory submissions is desirable
Ability to travel occasionally, 5% or less
Istari Oncology offers full-time employees the opportunity to participate in an excellent compensation and benefits package including a 401(K) and medical, dental, vision, STD, LTD and life insurance.
Internal Number: 001
About Istari Oncology
Istari Oncology, Inc. is a clinical-stage biotechnology company focused on bringing hope to patients through our novel immuno-oncology and immunotherapy platforms for the treatment of glioblastoma and a wide variety of tumors. We are committed to pursuing our mission to harnessing patients’ own immunity to target and sustain a lethal response to cancer.