Regulatory Strategy Senior Associate

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Regulatory Strategy Senior Associate based in Canada.

This is an opportunity to contribute to regulatory strategies that help advance innovative treatments and improve patient <outcomes.You> will support regulatory pathway planning, agency engagement, and strategic compliance across product development programs.The role offers exposure to complex regulatory questions spanning development, submissions, and commercialization <objectives.You> will work closely with cross-functional teams in a fast-paced, collaborative, and growth-oriented environment.Your expertise will help identify regulatory risks and opportunities while keeping programs aligned with evolving <requirements.As> part of a remote team, you will have opportunities to deepen your regulatory expertise and broaden your experience across clinical development.This position is part of a talent pool for upcoming opportunities as business needs evolve.

Accountabilities

• Develop and recommend regulatory pathways for assigned products, studies, and markets, ensuring strategies support broader development and commercialization objectives.
• Support regulatory agency engagement by contributing to meeting strategies, preparing briefing materials, and coordinating relevant documentation.
• Identify regulatory risks, opportunities, and compliance considerations to inform development plans and strategic decision-making.
• Collaborate with cross-functional teams to ensure regulatory strategies remain aligned with clinical development activities and applicable requirements.
• Prepare and support regulatory documentation and submissions as required throughout the product development lifecycle.
• Monitor regulatory timelines, milestones, and submission activities to support effective program execution.
• Maintain current knowledge of regulatory requirements, industry guidance, and evolving expectations across relevant markets.
• Use regulatory databases, submission tracking systems, and related tools to maintain accurate and timely regulatory information.

Requirements

• Bachelor’s degree in life sciences, regulatory affairs, pharmacy, or a related discipline, or equivalent professional experience.
• At least 4 years of experience in regulatory affairs, clinical development, or another relevant regulated environment.
• Previous experience working with vaccine and/or biologic products is required.
• Strong knowledge of FDA regulations is required, with experience or familiarity with additional global regulatory markets preferred.
• Knowledge of ICH-GCP, regulatory requirements, and clinical trial processes.
• Experience working with regulatory databases, submission tracking platforms, or similar systems.
• Strong strategic thinking, problem-solving, organizational, and analytical skills.
• Excellent written and verbal communication skills, with the ability to collaborate effectively with internal and external stakeholders.
• Strong attention to detail and the ability to manage multiple priorities in a fast-paced environment.
• A patient-focused mindset and a proactive, solutions-oriented approach.
• An advanced degree in regulatory affairs, pharmacy, or a related field is an asset.
• Experience in specific therapeutic areas, development phases, or supporting FDA and international regulatory submissions is preferred.

Benefits

• Fully remote opportunity available to candidates in Ontario or Quebec, Canada.
• Opportunity to contribute to regulatory strategies supporting the development of treatments that can improve patient health.
• Exposure to complex regulatory programs, cross-functional collaboration, and global life sciences development.
• Growth-oriented environment with opportunities for continuous learning and professional development.
• Opportunities to deepen expertise across regulatory affairs and clinical development.
• Flexible work environment designed to give employees space to perform at their best.
• Opportunity to join a broader talent pool for future regulatory opportunities as business needs evolve.