Consultant II

Responsibilities

• Lead regulatory review and approval of US and Canadian promotional, advertising, and digital materials
• Evaluate materials for consistency with approved labeling, scientific evidence, and fair balance requirements
• Conduct risk assessments and provide recommendations for compliant stakeholder communications
• Serve as the Regulatory Affairs representative on promotional review committees
• Collaborate with Medical, Legal, Commercial, and Compliance partners to facilitate material approval
• Provide strategic guidance regarding FDA, OPDP, Health Canada, and PAAB requirements
• Support promotional strategy for product launches, lifecycle management, and label changes
• Monitor regulatory developments and communicate business implications to stakeholders
• Develop training programs and best practices to strengthen promotional compliance

Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related discipline
• 3-5 years of experience in pharmaceutical, biotechnology, or regulatory environments
• Significant experience in advertising and promotional regulatory review
• Experience with multidisciplinary Medical/Legal/Regulatory (MLR) review processes
• Strong knowledge of FDA/OPDP and Health Canada/PAAB regulatory requirements
• Ability to evaluate clinical evidence, product labeling, and safety information

Preferred Qualifications

• Experience supporting both US and Canadian promotional review activities
• Direct experience with OPDP advisory submissions and PAAB preclearance processes
• Experience supporting product launches, digital campaigns, and omnichannel initiatives
• Familiarity with electronic promotional review systems and document management platforms
• Experience mentoring junior regulatory professionals

About the Company

Syner-G is a strategic biopharma product development and delivery partner that accelerates breakthrough science and the delivery of life-enhancing therapies to patients.