• We make platelets.

Director – Regulatory/CMC Program Manager

Hired talent will be responsible for leading regulatory strategy development / execution and regulatory management for early development programs based in on U.S. This position will also lead and contribute to activities in support of high-quality CMC sections of regulatory documentation.

Duties and Responsibilities

The position calls for duties that are broad and variable, with significant opportunity for advancement. Specifically, you will be responsible for:

  • Leading the kick-off of projects and overseeing the execution of product development plans by continually re-evaluating direction, resources and timelines.
  • Working closely with cross-functional internal stakeholders and external consultants to influence, develop and maintain alignment of program with milestones.
  • Ongoing risk assessment and exercise good judgement in elevating and communicating actual or potential issues.
  • Authoring IND sections and managing IND document build-out with cross-functional team leads.
  • Serving as the key interactor with FDA and all other agencies for in-person meetings with responsibility for all management of formal responses to agency queries.
  • Providing feedback and guidance in accordance with phase appropriate regulatory expectations.
  • Leading PBG responsibilities for regulatory inspections, audits, qualifications, etc.
  • Remaining current of FDA regulatory pathways and guidance’s and familiar with international agencies such as EMA and Health Canada.
  • Continually identifying gaps and leading process and system improvements.

Required Qualifications

  • Authorized to work in the U.S.
  • M.S. with 10+ years of regulatory experience in a cellular therapeutic program, or 15+ years in a relevant field.
  • Possess an open and collaborative approach with the ability to work well across dynamic teams.
  • Experience in cell-based therapeutics essential, detailed knowledge of allogenic products highly desired.
  • Aptitude in providing strategic advice on integrated regulatory development plans and executing the regulatory strategy.
  • A desire to work in a startup environment with demonstrated agility and ability to translate strategy into action plans.
  • Proven ability to prepare and submit documents to FDA, such as Investigational New Drug (IND).
  • In-depth working knowledge of US agency regulations, guidance, policies, and procedures.
  • Track record of building an excellent relationship with FDA and other regulatory agencies.
  • Exceptional writing, communication and presentation skills.

Benefits Include

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

Please send cover letter and CV/resume to: