Position Summary:

The primary role of this position is to provide regulatory support for the development of Gritstone’s oncology therapeutics from submission of original INDs through early phase clinical trials to worldwide submission and approval.

Specific responsibilities include:

  • Assist in the authoring and facilitate the team review of Clinical, Nonclinical, and CMC documents for submission to Health Authorities (INDs, CTAs, amendments, annual reports, meeting packages, etc.)
  • Assist with the regulatory aspects of new investigator submissions, annual reports, protocol revisions, and pharmacovigilance-related submissions (e.g., PSURs/DSURs) as needed including preparation of cover letters and forms
  • Coordinate with publishing vendors to compile and review regulatory submissions for completeness and quality, ensuring conformance with current health authority and industry submission standards
  • Assist with logging, tracking, and filing of correspondence with regulatory authorities
  • Help to ensure that all elements, quality, accuracy, and format of regulatory submissions and other documentation comply with applicable laws, regulations and standards
  • As assigned, perform literature searches, prepare special reports, and assemble documentation to support project teams
  • Maintain knowledge of global regulatory environment, regulations and guidelines
  • Participate in cross-functional subteams and working groups
  • Contribute to the development and maintenance of the Regulatory Affairs working practices and procedures

Minimum Education/Experience

  • Bachelor degree (or equivalent) in life sciences, Masters preferred
  • 2+ years of experience in the pharmaceutical industry, direct experience in regulatory affairs or related function preferred

Other Qualifications

  • Fundamental understanding of GxP
  • Good understanding of clinical development of novel therapeutics, with a focus on the IND process
  • Detail oriented with excellent oral and written communication skills, including proficiency in scientific writing
  • Strong organizational skills and ability to maintain a high level of communication, productivity, innovation, and priority-setting to work effectively in a dynamic environment to meet aggressive timelines
  • Self-motivated, self-disciplined, and able to function independently as well as part of a team
  • Excellent computer proficiency (MS Word, Excel, PowerPoint, Visio, Adobe Acrobat, and document management systems)
  • Experience with eCTD publishing systems