About Parexel
Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

About the Role
We are seeking a Regulatory Strategy Senior Associate to join our team in a remote capacity. As a Regulatory Strategy Senior Associate, you will support regulatory strategy initiatives that advance new treatments for patients. This position plays a key role in regulatory pathway planning, agency engagement support, and strategic compliance oversight. You'll collaborate with cross-functional teams, follow industry-standard processes, and contribute to regulatory strategy from planning through implementation. Responsibilities include developing regulatory pathway recommendations, supporting agency engagement planning, and identifying key risks and opportunities, with opportunities to deepen your expertise and influence regulatory outcomes.

You'll join a fast-paced, growth-oriented workplace focused on making a meaningful impact through strategic regulatory guidance and product development support. With diverse teams and continuous learning opportunities, the Regulatory Strategy Senior Associate can explore career paths and expand skills across regulatory affairs and clinical development.

Key Responsibilities

Develop and recommend regulatory pathways for assigned products, studies, or markets

Support agency engagement planning and prepare materials for regulatory meetings

Identify key regulatory risks and opportunities to inform development strategy

Align regulatory approaches with development and commercialization objectives





Maintain current knowledge of regulatory requirements and industry guidance

Collaborate with cross-functional teams to ensure regulatory compliance and strategic alignment

Prepare regulatory documentation and submissions as needed

Track regulatory timelines and milestones to support program execution

Candidate Profile
You’ll thrive in this role if you bring:

Strengths in regulatory strategy, strategic thinking, and problem-solving

Experience working in regulatory affairs, clinical development, or a regulated environment

The ability to collaborate across teams and communicate clearly with internal and external stakeholders

A patient-focused mindset and strong attention to detail

Comfort working with regulatory databases, submission tracking systems, and standard office tools

Required Qualifications

Bachelor's degree in life sciences, regulatory affairs, pharmacy, or related field, or equivalent professional experience

4+ years of experience in regulatory affairs, clinical development, or a related field

Previous experience with vaccine and/or biologic products is required

FDA regulation expertise/knowledge is required and experience with other global markets is preferred

Knowledge of ICH-GCP, regulatory requirements, and clinical trial processes

Experience with regulatory databases or submission tracking systems

Strong communication, organization, and problem-solving skills

Preferred Qualifications

Advanced degree in regulatory affairs, pharmacy, or related field

Experience in specific therapeutic areas or development phases

Familiarity with regulatory submission software or electronic tracking systems

Experience supporting FDA or international regulatory submissions

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

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📌 Regulatory Strategy Senior Associate (Ontario)
🏢 Parexel
📍 Ontario