Regulatory Strategy Senior Associate

📋 Description

• Develop regulatory pathways for products, studies, and markets.
• Support agency engagement with meeting strategies and materials.
• Identify regulatory risks to inform development plans.
• Collaborate cross-functionally to align strategies with development activities.
• Prepare and support regulatory documentation and submissions.
• Monitor timelines and submission activities for program execution.

🎯 Requirements

• Bachelor’s in life sciences, regulatory affairs, pharmacy, or related field, or equivalent
• 4+ years in regulatory affairs or regulated environments.
• Experience with vaccine and/or biologic products is required.
• Strong knowledge of FDA regulations; global regulatory markets pref..
• Knowledge of ICH-GCP and clinical trial processes.
• Experience with regulatory databases or submission tracking systems.

🎁 Benefits

• Fully remote opportunity for Ontario or Quebec, Canada.
• Opportunities to contribute to regulatory strategies that improve patient outcomes.
• Exposure to complex regulatory programs and cross-functional collaboration.
• Growth-focused environment with professional development.
• Deepen regulatory and clinical development expertise.
• Flexible work environment to perform at best.