Our clinical activities are growing rapidly, and we are currently seeking a full-time, Executive Director of US Regulatory Strategy
to join our team. This position is accountable for the development and implementation of the regulatory strategy for specific Sponsor projects, for ensuring that the strategy is designed to deliver a rapid approval with advantageous labeling in keeping with the properties of the product(s) and the needs identified by the team. The RAD possesses strategic leadership skills, has deep experience in North American (US and Canada) regulatory science and overall drug/biologic development processes and strategies. Experience and knowledge of therapeutic areas and drug development is an important enabler to being able to influence cross-functional discussions Sponsors and relevant stakeholders.

• Provide senior level, experienced regulatory leadership to satisfy expected industry standards, applying in-depth knowledge of regulatory requirements and guidelines, procedures and agency precedent.
• Advises project teams regarding the development and implementation of regulatory strategy through the clinical and nonclinical development processes.
• Lead and support regulatory and broader development teams on strategic projects including gap analyses, meetings with regulatory authorities, protocol synopsis development and review, and other strategic deliverables.
• Provide regulatory advice and guidance to Clinical Operations, Medical Writing, Clinical Safety/Pharmacovigilance, Data Management, and Biostatistics.
• Maintain advanced knowledge of changing regulatory requirements and advise teams as appropriate.
• Interact with appropriate national/regional government regulatory agencies; and
• Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges.

• PhD in life science degree or PharmD
• 10+ years of regulatory affairs experience in a CRO or Pharmaceutical industry