Senior Regulatory Affairs Consultant – Ad Promo Strategist, Health Canada Expertise

🔥 0 minutes ago

🇨🇦 Canada – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• 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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