Helping patients discover and access treatments
Regulatory Affairs Director
Location
Canada
Posted
9 days ago
Salary
0
Seniority
Lead
Job Description
Regulatory Affairs Director
myTomorrows
• Drive regulatory strategy execution • Translate company and RA/PV strategy into clear regulatory plans across programs and regions • Drive implementation across Expanded Access Programs (EAPs), Clinical Trials, and Real-World Data initiatives • Oversee program and portfolio delivery • Oversee multiple regulatory programs simultaneously, ensuring delivery against timelines, quality standards, and client expectations • Identify and proactively manage cross-program risks, dependencies, and resource constraints • Lead and develop the team • Lead, coach, and develop Regulatory Affairs Managers and senior team members • Set clear expectations and drive accountability for performance, quality, and delivery • Collaborate cross-functionally • Partner closely with Program Management, Medical Affairs, Quality Assurance, and Supply Chain • Ensure regulatory input is embedded into end-to-end program delivery • Drive operational excellence and performance • Drive standardization, consistency, and scalability of regulatory processes • Identify improvement opportunities and implement data-driven solutions • Engage with clients and stakeholders • Act as a senior point of contact for clients on regulatory matters • Support client discussions, audits, and regulatory interactions with Health Authorities • Ensure quality, compliance, and risk management • Ensure adherence to global regulatory requirements and internal processes • Support inspection readiness and audit preparedness
Job Requirements
- Advanced degree in life sciences, pharmacy, or related field
- Significant experience in Regulatory Affairs within pharma, biotech, or CRO environments
- Proven experience managing multiple programs and complex regulatory portfolios
- Strong knowledge of global regulatory frameworks (EAP, clinical trials, or similar environments)
- Demonstrated leadership experience managing teams and developing talent
- Excellent stakeholder management and communication skills
Benefits
- Equal Opportunity Employer
- Discrimination-free practices
- Commitment to cultivating a diverse workplace
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