Regulatory Operations Specialist

Research Associate – Bioreactor Team
April 11, 2018
Senior Research Associate – Cell Biology
April 11, 2018

Regulatory Operations Specialist

We are currently seeking a Regulatory Operations Specialist to help support the Chief Scientific Officer and Chief of Staff with the preparation of FDA, etc applications with consultants, as well as coordination with collaborators with cGMP-compliant work.

We are currently seeking a Regulatory Operations Specialist to help support the Chief Scientific Officer and Chief of Staff with the preparation of FDA, etc applications with consultants, as well as coordination with collaborators with cGMP-compliant work.

 

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.

 

Benefits Include

  • Medical, Dental, Vision Insurance
  • Retirement Planning (401k)
  • Unlimited vacation/sick days
  • Parental Leave
  • Commuter Discounts and much more!

 

Please send cover letter and CV/resume to:

info@plateletbiogenesis.com