Manager/Sr. Manager, Regulatory Affairs

Regulatory · Durham, North Carolina
Department Regulatory
Employment Type Full-Time
Minimum Experience Manager/Supervisor

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

 

Minimum Requirements:

  • 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.

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  • Location
    Durham, North Carolina
  • Department
    Regulatory
  • Employment Type
    Full-Time
  • Minimum Experience
    Manager/Supervisor