Canadian Regulatory Strategists (Senior Regulatory Affairs Associate / Consultant)
Parexel · Canada
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
About Parexel
Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.
We work with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart®.
About the Role
We are seeking experienced Canadian Regulatory Strategists at the Senior Regulatory Affairs Associate and Regulatory Affairs Consultant levels to join our team in a remote capacity. As a Canadian Regulatory Strategist, you will support and execute Canadian regulatory strategies for vaccine and biologic programs across development, registration, and post-authorization lifecycle activities. Your work helps bring new vaccines and biologic therapies to patients in Canada and advances clinical research. This position plays a key role in Canadian regulatory strategy, Health Canada interactions, regulatory submissions, and labelling and lifecycle compliance. You will collaborate with global regulatory and cross-functional teams, apply strong knowledge of Health Canada requirements, and contribute to regulatory decisions from planning through post-approval activities. Responsibilities include Canadian regulatory strategy development, Health Canada interactions, regulatory submissions, global regulatory collaboration, labelling and lifecycle management, regulatory intelligence, and cross-functional collaboration, with opportunities to deepen your expertise and influence regulatory outcomes.
You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through strategic Canadian regulatory support, timely and compliant Health Canada submissions, and close partnership with global regulatory and cross-functional teams. With diverse teams and continuous learning opportunities, as a Canadian Regulatory Strategist you can explore different career paths and expand skills across regulatory affairs and clinical research.
Key Responsibilities
- Develop, support, and execute Canadian regulatory strategies that align with global development, registration, and lifecycle management plans.
- Support or lead Health Canada interactions, including meeting preparation, responses to agency questions, regulatory issue resolution, and management of commitments.
- Plan, coordinate, review, and support the execution of Canadian regulatory submissions, including Clinical Trial Applications (CTAs), New Drug Submissions (NDSs), Supplemental New Drug Submissions (SNDSs), and post-authorization submissions.
- Represent Canadian regulatory requirements and perspectives within global regulatory teams, contributing to regulatory strategy, submission planning, and decision-making.
- Support Canadian Product Monographs, labelling updates, regulatory compliance, and post-approval activities.
- Monitor and interpret evolving Health Canada regulations, guidelines, and policies, and assess their potential impact on assigned programs.
- Partner with Clinical, CMC (Chemistry, Manufacturing, and Controls), Safety, Medical, Commercial, and global Regulatory teams to ensure timely and compliant regulatory deliverables.
Candidate Profile
You'll thrive in this role if you bring:
- Practical Canadian regulatory strategy experience and direct Health Canada exposure
- The ability to operate effectively within a global regulatory organization and contribute beyond submission coordination or regulatory operations
- Strengths in regulatory writing and review, organization, and problem-solving
- The ability to collaborate across teams and communicate clearly
Required Qualifications
- Degree in life sciences, pharmacy, or a related scientific discipline
- Senior Regulatory Affairs Associate: approximately 5-8 years of relevant experience in Canadian Regulatory Affairs
- Regulatory Affairs Consultant: approximately 8+ years of relevant experience in Canadian Regulatory Affairs
- Strong working knowledge of Health Canada regulations, regulatory pathways, and submission requirements
- Hands-on experience with Canadian regulatory submissions, particularly New Drug Submissions (NDSs), Supplemental New Drug Submissions (SNDSs), and post-authorization activities
- Experience working with global regulatory teams and cross-functional stakeholders
- Strong communication, organization, problem-solving, and regulatory writing and review skills
Preferred Qualifications
- Experience with vaccines, biologics, or other complex products
- Experience within the pharmaceutical, biotechnology, or vaccine industry
- Hands-on experience with Clinical Trial Applications (CTAs)
Due to the client's location, candidates located in the eastern or central time zone of Canada are strongly preferred.
We offer a comprehensive benefits package and competitive salaries based on several factors, including the position and level offered, skills, education, training, experience, professional achievements, and location.
Some roles may also be eligible for additional incentives, bonuses, or other compensation programs. Our Talent Acquisition team will provide details on applicable bonus plans or incentive structures for eligible positions.
If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!
We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.
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