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Director of Regulatory Affairs
Confirmed live in the last 24 hours
Vancouver, BC, Canada
Experience Level
  • A minimum of a Bachelor's and or undergraduate degree in biological, pharmaceutical, chemical or engineering sciences is required
  • 7-10 years of experience inclusive of postgraduate education and/or Advanced scientific degree preferred in the sciences, or health related field
  • Knowledge of EMA and FDA regulations is required. Experience in filing regulatory submissions required
  • Experience in biologics is preferred
  • Experience directly writing submission documents is preferred
  • Leading program teams in preparing regulatory submissions including briefing documents, IND and CTA filings
  • Overseeing preparation of responses to all regulatory authority queries
  • Planning and leading meetings with regulatory authorities
  • Managing critical clinical regulatory timelines, working with team members to resolve issues related to non-clinical studies, and clinical development, and working in partnership with the CMC team
  • Serving as the primary regulatory representative at internal meetings as well as at meetings with regulatory agencies for all clinical related issues
  • Maintaining detailed knowledge of global regulatory environment relevant for biologics including accelerated review programs. Communicating changing regulatory agency requirements, and supporting pertinent regulatory intelligence per needs of programs
  • Collaborating with external consultants, clinicians, CROs to provide regulatory guidance
  • Evaluating regulatory program risks and establish mitigation strategies pertinent to clinical development
  • Partnering with CMC, Discovery, and Clinical Development organizations to innovate strategies to accelerate submission timeline
  • Escalating issues to Management that affect regulatory compliance
  • You have a strong knowledge of eCTD elements and structure, and regulatory writing skills
  • You have demonstrated knowledge of regulatory requirements in the design and conduct of clinical trials, including preparation of regulatory submissions
  • You can manage contract staff and vendors as needed to support regulatory activities
  • You have exceptional interpersonal skills that promote a collaborative and productive lab environment
  • You have effective and efficient written and oral communication skills
  • You are able and excited to work in a fast-paced environment, handling multiple responsibilities simultaneously
  • You have strong attention to detail and excellent organizational skills with an ability to prioritize effectively to deliver results within reasonably established timelines
  • You work effectively both independently and as part of a team
AbCellera Biologics
Company Overview
AbCellera Biologics is a biotechnology company that develops antibody therapeutics to improve patient outcomes.