Regulatory Operations Specialist

Dr. Jonathan Thon Tells the Story of How Platelet Biogenesis Came to be at iCons Fall Workshop
December 20, 2017
Cell Culture Process Engineer (MS/PhD level)
January 8, 2018

Regulatory Operations Specialist

We are looking for a driven independent thinker with a monster work ethic that shares our long‐term vision for a donor‐independent blood system. Initiative and creative problem solving are priorities since you’ll be partnering with us to fundamentally disrupt a firmly established industry.

We are looking for a driven independent thinker with a monster work ethic that shares our long‐term vision for a donor‐independent blood system. Initiative and creative problem solving are priorities since you’ll be partnering with us to fundamentally disrupt a firmly established industry.

 

Duties and Responsibilities

Because we are a startup, the position calls for duties that are broad and variable, with significant opportunity for advancement. If you want the chance to own the regulatory process from start to finish and exposure to a startup culture, this is a perfect opportunity!

Specifically, you will be responsible for:

FDA Applications

  • Write and edit Pre-IND, IND, BLA, etc applications.
  • Communicate with teams to both update data and protocols.
  • Coordinate with established regulatory consultants and reach out to others for help.
  • Keep abreast of the latest regulatory pathways, guidelines, and opportunities.
  • Identify and assess regulatory risks for assigned projects or programs.
  • Coordinate this work with other funding opportunities, including BARDA, DoD, etc.
  • Communicate with regulatory agencies relevant to assigned projects, as appropriate.
  • Prepare IRB protocols associated with applications.
  • Manage and maintain documentation for regulatory inspections, audits, etc.

Project Coordination

  • Coordinate with external collaborators on cGMP-compliance paperwork, etc needed for applications, grants.
  • Establish and maintain communication between teams and external collaborators in regard to regulatory, deliverables, and cGMP-compliance needs.
  • Participate in negotiations with potential cGMP-compliant collaborators.
  • Collaborate with domestic and international colleagues regarding license renewals and updates.

Other

  • We’re a startup – everyday is different!
  • Communicate with upper management and board members on the application process.
  • Maintain files and databases as required.
  • Mentor other personnel on regulatory applications, processes, pathways, etc.

Qualifications

  • M.S. in relevant field and at least 5 years of relevant experience required, with 10+ years preferred.
  • Experience in cell-based and/or drug delivery therapeutics is preferred.
  • Experience in comparable roles in startups and/or biotechnology with domestic and international regulatory standards required.
  • Can work productively and develop cohesive team relationships.
  • Ability to manage change with a positive proactive approach.
  • High degree of computer literacy in Mac/PC based OS environments.
  • Good oral and written communication skills.
  • Must be able to logically and effectively structure tasks and set priorities.

 

Please send cover letter and CV/resume to:

info@plateletbiogenesis.com