Istari Oncology seeks a Manager/Sr. Manager, Regulatory Affairs for immediate hire in our Durham, NC offices. The selected individual will be responsible for 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
- Coordinates IND maintenance activities, including tracking, document development, publishing, and submission activities for company programs
- Authors and reviews regulatory submission documents, including DSURs, ODD annual reports, information amendments, meeting requests, briefing documents, etc.
- Provides senior leadership and project teams with technical guidance on regulatory requirements to maintain compliance
- Assess and monitor company regulatory compliance with SOPs, study protocols, industry standards, and regulatory requirements
- Manages external vendors to support regulatory operations activities, as needed
- Assists QA and other staff with regulatory agency inspections and audit activities, 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.
Istari Oncology, Inc. is a clinical-stage biotechnology company focused on novel immuno-oncology and immunotheraphy platforms for the treatment of glioblastoma and a wide variety of tumors.