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.

We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart .

We are seeking a Chemistry, Manufacturing, and Controls (CMC) Strategy Senior Associate / Consultant (CMC Regulatory Affairs) to join our team in a remote capacity. As a CMC Strategy Senior Associate / Consultant, you will lead and contribute to CMC regulatory strategy for biologics and vaccines, supporting patients worldwide. This position plays a key role in global product lifecycle activities, regulatory submission quality, and global regulatory compliance. Responsibilities include shaping CMC regulatory strategies, authoring and reviewing CMC documentation, and performing dossier gap analyses, with opportunities to deepen your expertise and influence strategy and regulatory outcomes.
You will join a fast-paced, growth-oriented environment focused on making a meaningful impact through global submissions, lifecycle management, and long-term client partnerships. You will gain global exposure across US, EU, and international regulatory landscapes, With diverse teams and continuous learning opportunities, the CMC Strategy Senior Associate / Consultant can explore career paths and expand skills across global CMC regulatory strategy.
Lead and contribute to CMC regulatory strategies for global product lifecycle activities, including variations and post-approval changes.




Author and review high-quality CMC documentation (Modules 1-3) for global submissions.
Support and lead global submissions (US, EU, and beyond) from planning through execution.
Perform CMC dossier gap analyses and provide clear, strategic recommendations.
Partner cross-functionally with Regulatory, Quality, Manufacturing, and client stakeholders.
Act as a key contributor within a dedicated client team, building strong, trusted relationships.
Ensure submissions meet global regulatory expectations with precision and excellence.
Strengths in CMC regulatory strategy, CMC Modules 1-3 authoring and review, and dossier gap analysis
Experience in CMC Regulatory Affairs or CMC Strategy within a regulated biopharmaceutical environment
A patient-focused mindset, a commitment to quality and integrity, and strong attention to detail
Comfort working with global submission processes and regulatory documentation standards
3+ years of experience in CMC Regulatory Affairs or CMC Strategy for a Senior Associate role and 5+ years of experience for a Regulatory Affairs Consultant role

- Hands-on experience with commercial biologicals and/or vaccines
- Strong knowledge of global regulatory requirements (FDA, EMA, and international markets)
- Expertise in authoring and reviewing CMC Modules 1-3 to support variations and performing gap analyses
- Parexel offers a comprehensive advantages package to eligible employees and we offer competitive salaries based on several factors, including the position and level offered, skills, education, training, experience, professional achievements, and location.

Some roles may also be eligible for additional incentives, bonuses, or other compensation programs. Our Talent Acquisition team will provide details on applicable bonus plans or incentive structures for eligible positions.
Join us and be part of a team where your contributions help shape the future of clinical research.

#LI-REMOTE

📌 Regulatory Affairs Specialist (Remote) (Canada)
🏢 Important Group
📍 Canada