What are the responsibilities and job description for the Director, Regulatory Affairs position at Jobgether?
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Director, Regulatory Affairs in Canada.
This senior leadership role sits at the intersection of regulatory strategy, drug development, and health authority engagement within a global biopharmaceutical environment. The position plays a critical role in shaping Canadian regulatory pathways for innovative therapies across oncology and neuroscience. You will act as the key regulatory representative for Canada, ensuring alignment with Health Canada requirements while influencing global regulatory strategies. The role involves close collaboration with global regulatory teams, scientific experts, and senior stakeholders across multiple regions. It offers high visibility and impact in advancing the approval and lifecycle management of life-changing medicines. This is a strategic, cross-functional position requiring both scientific depth and strong leadership capabilities.
\n- Serve as the Canadian Regulatory Lead, acting as the Regulatory Responsible Person and key point of contact for Health Canada interactions.
- Provide strategic and operational regulatory guidance for clinical development, marketing authorization, labeling, and post-approval activities in Canada.
- Collaborate with Global Regulatory Leads and cross-functional teams to define regulatory strategies and ensure alignment across development programs.
- Lead interactions and negotiations with Health Canada, including resolution of regulatory issues and support for expedited approvals and labeling discussions.
- Monitor and interpret evolving regulatory frameworks and assess their impact on product development and business strategy.
- Contribute to global submissions, lifecycle management, and international expansion activities across multiple regions.
- Support Health Canada inspections and ensure compliance with internal regulatory processes, SOPs, and governance standards.
Requirements:
- Bachelor’s degree in a scientific or health-related field; advanced degree (Master’s or higher) strongly preferred.
- Extensive experience in Regulatory Affairs within the pharmaceutical or biopharmaceutical industry.
- Proven experience acting as a Responsible Person and leading regulatory submissions such as CTAs and NDSs.
- Strong understanding of Health Canada regulations, drug development processes, and global regulatory frameworks.
- Demonstrated ability to develop and execute regulatory strategies across multiple product lifecycles.
- Excellent negotiation, communication, and stakeholder management skills in cross-functional and international environments.
- Strong analytical and problem-solving abilities with the capacity to interpret complex regulatory issues.
- Fluency in English, both written and spoken, with the ability to communicate complex regulatory concepts clearly.
Benefits:
- Competitive base salary ranging from approximately 180,000 to 270,000 CAD depending on experience and qualifications.
- Eligibility for annual bonus and long-term incentive compensation programs.
- Comprehensive benefits package including extended health care, dental coverage, life insurance, and disability coverage.
- Retirement savings plan (RRSP) and paid vacation.
- Fully remote work arrangement within Canada.
- Opportunity to contribute to innovative therapies in oncology and neuroscience with global impact.
- Exposure to international regulatory environments and cross-functional leadership roles.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Why Apply Through Jobgether?
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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