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.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1