Head of Regulatory Operations

Location
Seattle, South San Francisco, CA, United States
Posted
Apr 18, 2021
Ref
5149121002
Required Education
Other
Position Type
Full time
JOB PURPOSE

Sana was founded by a team of experienced biotech executives, scientific pioneers in gene therapy and cell therapy, and investors with the goal of creating the leading company in the new era of medicine based upon the ability to engineer cells. The company is headquartered in Seattle, with offices in San Francisco and Cambridge, MA, and it has licensed technology from a number of leading academic institutions, including Harvard University; University of California, San Francisco; the University of Washington; and King's College in London. Sana has raised significant capital since its founding, with investments from a number of leading venture capital firms (including ARCH Venture Partners, Flagship Pioneering, F Prime, and Google Ventures) along with leading institutional investors.

Sana Biotechnology is looking to expand our team with hard-working individuals who believe in the potential of cells as engineered medicines, have the vision to do creative things, and the determination to execute that vision. Works on projects of diverse scope. Exercises judgement within broadly defined practices to select methods, techniques and evaluation criteria. Demonstrated success in technical proficiency, scientific creativity, collaboration and independent thought.

DUTIES AND RESPONSIBILITIES
  • Establish strategies and infrastructure for regulatory operations including all regulatory documents, submissions and archiving across the product lifecycle
  • Develop and implement high-quality technologies that meet current and future requirements and standards from global regulatory authorities
  • Be responsible for all regulatory IT systems for regulatory submissions. Serve as the point of contact to interface with Sana's IT management
  • Design and manage an integrated regulatory document management and publishing system. Ensure the highest standards applied consistently to regulatory systems and processes
  • Lead internal efforts and participate in discussions with regulatory authorities on issues related to electronic submissions or other IT issues. Formulate plans to solve them
  • Assist the Head of Regulatory Affairs and Strategy to plan the budget for, and control the costs of, regulatory operations including identifying and implementing outsourcing opportunities (e.g., regulatory consultants)
  • Build strong relationship and collaborate with Sana's cross-functional program teams ensuring timely delivering critical global submissions
  • Train and mentor employees on regulatory affair operations

QUALIFICATIONS
Basic Qualifications

  • Bachelor or advanced degree in a scientific or technical discipline
  • More than 10 years of industry experience, preferably at least 5 years of regulatory publishing, submission and / or operation
  • Tracked record of regulatory publishing, submission, regulatory operation, process, and IT systems experience
  • Rich and demonstrated skills and experience in interactions with regulatory authorities
  • Excellent writing, interpersonal communications, organizational, and presentation skills
  • Established leadership and management skills with cross-functional teams
  • Demonstrated experience with budgeting and planning
  • Strong leadership, strategic orientation, project management, development of people, and process

WORKING CONDITIONS
  • Office based role that requires travel to and from other Sana locations and regulatory agencies as needed