Regulatory Affairs Director

About the role

You will architect and execute the global regulatory strategy that underpins our expanding portfolio of therapies and services. This position requires a leader who can synthesize complex regulatory landscapes into coherent, actionable plans for diverse therapeutic programs. You will own the end-to-end regulatory lifecycle for key initiatives, ensuring that every submission and interaction aligns with our quality and compliance benchmarks. The role places you at the intersection of science, policy, and business, where your decisions will shape the trajectory of our programs. You will act as the primary regulatory strategist for our operations, translating high-level objectives into detailed implementation roadmaps. Furthermore, you will mentor the next generation of regulatory professionals, fostering a culture of rigor, curiosity, and accountability. Success in this position will be defined by your ability to deliver seamless regulatory execution while safeguarding the integrity of our processes.

Key facts

What you'll do

• Architect global regulatory plans by translating corporate and pharmacovigilance strategies into program-specific implementation roadmaps for diverse therapeutic areas.
• Deploy and monitor complex regulatory strategies across Expanded Access Programs (EAPs), Clinical Trials, and Real-World Data initiatives to ensure seamless execution.
• Orchestrate multiple concurrent regulatory programs, establishing governance structures to meet aggressive timelines while maintaining uncompromising quality standards and client satisfaction.
• Conduct proactive risk assessment to identify dependencies, resource constraints, and strategic bottlenecks, then develop mitigation plans to safeguard program momentum.
• Cultivate and direct a team of Regulatory Affairs Managers and senior professionals, focusing on leadership development, performance management, and skills enhancement.
• Institute and enforce clear performance, quality, and delivery expectations, creating a framework that promotes consistency and accountability across the regulatory function.
• Forge strategic partnerships with Program Management, Medical Affairs, Quality Assurance, and Supply Chain teams to ensure regulatory considerations are embedded in every operational decision.
• Integrate regulatory expertise throughout the program lifecycle, from initial concept development through execution and closure, to ensure continuous compliance and value realization.
• Pioneer standardized regulatory processes and operational frameworks that enable scalability, efficiency, and excellence across the organization.
• Analyze program data and outcomes to identify systemic improvement opportunities, implementing data-driven solutions that enhance regulatory efficiency and effectiveness.
• Serve as the principal regulatory advisor for client engagements, articulating complex regulatory positions with clarity and confidence to senior stakeholders.
• Lead client-facing discussions, audits, and interactions with Health Authorities, representing Mytomorrows with professionalism and expertise.
• Ensure rigorous adherence to global regulatory requirements and internal processes, maintaining a robust compliance posture across all activities.
• Collaborate closely with internal stakeholders to prepare for regulatory inspections and audits, ensuring all documentation and readiness are exemplary.

Requirements

• Hold an advanced degree in life sciences, pharmacy, or a closely related scientific discipline, demonstrating deep subject matter expertise.
• Possess significant, hands-on experience in Regulatory Affairs within pharmaceutical, biotech, or Contract Research Organization (CRO) environments.
• Have a proven track record of managing multiple, simultaneous programs and complex regulatory portfolios across various jurisdictions.
• Demonstrate a strong, working understanding of global regulatory frameworks, policies, and strategies, including extensive experience with Expanded Access Programs and clinical trial regulations.
• Show clear evidence of leadership experience in managing, coaching, and developing high-performing teams within a regulated environment.
• Exhibit excellent skills in stakeholder management, communication, and influence, navigating complex organizational landscapes with ease.
• Hold the right to work and reside in Canada, specifically within the Eastern Standard Time or Central Standard Time zones, to guarantee real-time collaboration.
• Display a commitment to ethical conduct and integrity, with a thorough understanding of the regulatory obligations that govern our industry.
• Bring a meticulous attention to detail and a methodical approach to problem-solving, ensuring accuracy in all regulatory submissions and communications.
• Demonstrate resilience and adaptability in a dynamic, fast-paced environment where priorities may shift rapidly.

Nice to have

• Experience scaling regulatory operations in a growing or multi-site pharmaceutical or biotech organization.
• Familiarity with regulatory intelligence tools and databases used to track global regulatory changes.
• Background in implementing quality management system (QMS) initiatives within a regulatory context.
• Knowledge of health technology assessment (HTA) or pricing and reimbursement landscapes in key markets.
• Experience with digital health or decentralized clinical trial regulatory strategies.

Practical notes

Applicants must reside within the EST or CST time zones to ensure effective collaboration.