Facebook pixel

Director – Regulatory Affairs
Confirmed live in the last 24 hours
Seattle, WA, USA
Experience Level
Desired Skills
  • This role can be based anywhere in the US, with a preference for the Seattle or Boulder area
  • Ability to travel occasionally
  • Independently provide effective phase-appropriate strategic guidance/input related to current regulatory requirements and expectations for clinical trial applications and marketing applications for development projects
  • Plan, prepare, and manage submissions to HAs including DMFs, INDs, NDA/BLA and CTD regulatory filings
  • Lead regulatory interactions with HAs including managing preparation of briefing materials for HA meetings, preparing subject matter experts (SMEs), and ensuring appropriate follow-up
  • Work in close collaboration with consultants and/or CROs, as needed, to ensure appropriate interactions with HAs
  • Utilize various electronic systems for dossier creation and tracking
  • Represent the regulatory function on cross-functional product development teams and provide innovative strategic and tactical advice to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements
  • Effectively communicate the regulatory strategy, risks, mitigations and overall plans to Regulatory Affairs, program teams and senior management, as relevant
  • Identify, communicate, and propose resolutions to both routine and complex issues
  • Remain current on Regulatory Intelligence, new guidance documents and competitive information to provide comprehensive information to program teams
  • Support or lead non-project activities, as needed such as SOP/standards development
  • BS/BA degree (or equivalent) in a relevant scientific field required; advanced degree (MS or PhD) is preferred
  • A minimum of 10 years of experience in regulatory affairs with a focus on regulatory documentation and lifecycle management within the pharmaceutical or biotechnology industry is a must, including 3 years of experience in management/leadership roles
Desired Qualifications
  • Experience with oncology products is desired
  • Knowledge of regulatory requirements across development stages and post-approval is essential. Experience with regulations for:
  • Biologics and small molecules is required
  • Cell/gene therapy is desired
  • Combination products is desired
  • Expert working knowledge of full drug development process and knowledge of FDA and ICH regulatory requirements
  • Strong strategic and analytical abilities, diplomacy, and negotiation skills
  • Ability to collaboratively influence across multiple functions, and motivate others to accomplish company objectives
  • Ability to work flexibly within tight timelines and with strong project management skills
  • Self-motivated and detail oriented with sound judgement and innovative thinking to deal with challenges/opportunities
Umoja Biopharma

51-200 employees

Immunotherapy biopharmaceutical company