Regulatory consultant reviewing Canadian pharmaceutical advertising and promotional materials for Parexel’s life sciences clients. Applying Health Canada, Product Monograph, and PAAB requirements.
Responsibilities
Review Canadian promotional, educational, medical, and corporate communications for alignment with relevant regulatory requirements, approved product information, and industry standards
Apply knowledge of Health Canada advertising requirements, the Canadian Product Monograph, and applicable PAAB standards
Provide regulatory input on content, messaging, and presentation of materials
Identify compliance considerations and recommend practical solutions
Represent Canadian Regulatory Affairs in Promotional Material Review Team and Medical Review Committee discussions, as applicable
Collaborate with Marketing, Medical, Legal, and other partners to facilitate efficient review and approval through established internal processes
Support the Canadian adaptation of global materials
Provide guidance on promotional versus non-promotional communications
Maintain alignment with Canadian Regulatory leadership and the broader Regulatory Ad Promo team
Escalate significant regulatory concerns as appropriate
Requirements
University degree in a scientific or health sciences discipline (e.g., Life Sciences, Pharmacy, Biology, or Chemistry) or a related field
At least five years of relevant experience in pharmaceutical or biotechnology Regulatory Affairs, including at least two years of advertising and promotional review experience
Working knowledge of Canadian pharmaceutical advertising requirements, Health Canada guidance, and the PAAB Code, with experience participating in cross-functional material review
Strong regulatory judgment, communication, and collaboration skills
Ability to work independently, manage priorities, and provide clear, solutions-oriented recommendations
Experience in pharmaceutical or biotechnology Regulatory Affairs, with exposure to advertising and promotional review
Ability to collaborate across teams and provide clear, solutions-oriented recommendations
Commitment to ensuring materials are compliant and appropriate for their intended audiences
Comfort participating in cross-functional review processes and established internal approval processes
Additional education or certification in Regulatory Affairs is considered an asset
Experience with FDA advertising and promotion requirements is preferred
Benefits
Comprehensive benefits plan for eligible Canadian employees
Competitive salaries
Some roles may be eligible for additional incentives, bonuses, or other compensation programs
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