Director, Regulatory Affairs

📋 Description

• Senior regulatory leadership for life-changing therapies
• Lead regulatory writing, strategies, and submissions (IND/NDA/BLA)
• Engage health authorities and prepare agency communications
• Partner with cross-functional teams across development stages
• Support business development and client opportunities
• Mentor regulatory staff to ensure quality and collaboration

🎯 Requirements

• Bachelor in science, toxicology, pharmacology, engineering or related field; advanced degree
• 10+ years within CRO or pharma; 5+ years leading projects
• Strong knowledge of ICH-GCP and international regulatory requirements
• Experience with regulatory strategy and submissions across Phases I–IV
• Excellent regulatory writing, communication, and presentation skills
• Proven leadership and ability to manage priorities in a team

🎁 Benefits

• Estimated US hiring range of $195,000–$223,000 plus bonus
• Fully remote working environment (Canada region)
• Flexible time off and paid holidays
• Medical insurance, tuition reimbursement, retirement plans
• Opportunity to work with an international team
• Inclusive, collaborative workplace culture