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When autocomplete results are available use up and down arrows to review and enter to select. Touch device users, explore by touch or with swipe gestures. Radius: Enter distance 5 15 25 35 50 Unit MILES KM View Remote Jobs View All Jobs View remote jobs View all jobs Regulatory Affairs Consultant
- CMC US/EU
- Mature Biological products Primary

Location:
Canada, Ontario, Remote Additional Locations: Canada, Alberta, Remote; Canada, British Columbia, Remote; Canada, Manitoba, Remote; Canada, New Brunswick, Remote; Canada, Newfoundland and Labrador, Remote; Canada, Northwest Territories, Remote; Canada, Nova Scotia, Remote; Canada, Nunavut, Remote; Canada, Prince Edward Island, Remote; Canada, Quebec, Remote; Canada, Saskatchewan, Remote; Canada, Yukon, Remote Job ID R0000047238 Category Regulatory / Consulting Date Posted 10/20/2026 Apply Now
• Success profile
• About this role
• Employee insights
• Why Consultants work at Parexel
• Learn about our culture Overview As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there. We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team. Success Profile Do you have these soft skills and interpersonal traits to succeed at Parexel?
• Communicator
• Detail-oriented
• Problem-solver
• Relationship-builder
• Results-driven
• Strategic Back to nav About This Role 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. We work with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies. 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.

About The Role
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. You will work within a dedicated client program, partnering closely with a leading organization to drive high-impact submissions and lifecycle management activities from planning through execution. 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. This is more than a delivery role. It is an opportunity to become a trusted advisor, influence strategy, and see your work directly contribute to patient outcomes. 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.

Key Responsibilities
• 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. Candidate Profile You'll Thrive In This Role If You Bring
• 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 setting
• The ability to collaborate across teams, manage stakeholders, and communicate clearly
• 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 Required Qualifications
• 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)
• Proven experience in global submission management
• Expertise in authoring and reviewing CMC Modules 1-3 to support variations and performing gap analyses




• A collaborative mindset with strong communication and stakeholder management skills Preferred Qualifications
• Experience with Veeva Vault (RIM/eCTD systems) Due to the client’s location, candidates located in the eastern time zone of Canada are preferred. Consideration, however, will be given to exceptional candidates located in other Canadian time zones provided there is flexibility to work ET hours. Parexel offers a comprehensive benefits 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. If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply 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. Back to nav Share this job
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• Email Employee Insights How to describe Parexel culture in one word Insights from Parexel employees Watch Video Jo on diverse project work and team culture Jo Wang | Vice President, Technical Watch Video Kurt on colleagues and growth opportunities Kurt Brorson | Vice President, Technical Watch Video Back to nav Why Consultants work at Parexel Patient-led in everything we do We are inspired by the patients behind the data and therefore deliver first-time quality and on-time projects. Supportive and inclusive environment We thrive on collaboration, caring, and inclusivity
- enabling our people to work together to solve complex problems and share knowledge. Opportunities for career growth We provide a wide range of challenging assignments, product types, geographic regions, and therapeutic areas, providing ample opportunities for learning and growth. Flexible work arrangements

We offer
the flexibility of remote work, allowing you to balance your personal and professional responsibilities while still contributing to our “We Care” team environment. Diverse and global client exposure We continuously learn by working with a global network of colleagues and clients to develop regulatory strategies to support their product development and approval. Learn from experts You will work with a team of highly experienced regulatory professionals who can serve as mentors, providing guidance and support as you develop your skills and advance in your career. Back to nav Learn About Our Culture Back to nav Back to nav
• Emerging Talent Opportunities Begin your career journey at Parexel with our emerging talent programs or our internships, placements and entry-level clinical roles. Advance science by keeping the patients in mind. Learn More
• Benefits & Support At Parexel, we prioritize putting people first, allowing you to achieve your best work. Explore the Flexible Work Program, our "Bravo" Recognition Program, and how we build our well-being in our supportive culture. Learn More
• Inclusion at Parexel Learn how Parexel celebrates the differences our workforce and patients bring and ensures an inclusive environment. Learn More

📌 Regulatory Affairs Consultant (Canada)
🏢 ATLAS MEDICAL SERVICES LTD. STI.
📍 Canada