Associate Director – North American Regional Leader

• Establish North American content requirements and timing for global dossier plans including BLA/NDAs, IND/CTAs & supplements.
• Serve as primary point of contact for US FDA.
• Lead the regulatory response team for FDA and Health Canada questions.
• Key contributor to regulatory submission strategy, identifying submission risks and opportunities, while leading regulatory applications and managing procedures through approvals.
• Manage routine maintenance submissions, coordinate NA post-approval commitments, provide input and review submission documents, as well as ensures approvals before dispatching to regulatory authorities.
• Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
• Provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s).

• Minimum of a Bachelor's degree in scientific or equivalent discipline
• Bachelor's degree plus 8+ years relevant experience OR;
  Master's degree/ PharmD plus 6+ years relevant experience, OR;
  PhD plus 4+ years relevant experience
• Relevant regulatory experience and understanding of clinical drug development, working with US FDA and global regulatory health authorities
• Experience responding to FDA and other Health Authorities (HA) requests and managing Health Authorities interactions
• Experience in lifecycle management of IND/NDA and other regulatory submissions
• Demonstrated experience in critically reviewing and compiling regulatory documents is required

Expertise in regulatory submissions and interactions with US FDA and Health Canada, with a strong background in clinical drug development and lifecycle management of IND/NDA submissions. Proven ability to develop and execute submission delivery plans while ensuring compliance with health authority requirements.

• Regulatory Submission Strategy
• FDA Interaction Management
• IND/NDA Lifecycle Management
• Regulatory Document Review
• Clinical Drug Development

• Regulatory Submission
• Clinical Drug Development
• Document Compilation Submission Delivery Plans
• Regulatory Expertise

• Stakeholder Communication
• Team Leadership
• Risk Identification

• Bachelor's Degree
• Master's Degree
• PharmD
• PhD

• BLA
• NDA
• IND
• CTA
• Health Authorities
• Regulatory Compliance