I contribute to clinical research with expertise and empathy. And I do it
Regulatory Affairs CMC Senior Associate / Consultant - Biologics or Vaccines
Primary Location: Canada, Ontario, Remote Additional Locations: Canada, New Brunswick, Remote; Canada, Newfoundland and Labrador, Remote; Canada, Nova Scotia, Remote; Canada, Quebec, Remote Job ID R0000042155 Category Regulatory Affairs Date Posted 05/20/2026Overview
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
About This Role
Make an Impact Where It Matters Most
Are you ready to play a critical role in bringing life-changing biologics and vaccines to patients worldwide?
We’re looking for a CMC Strategy Senior Associate / Consultant who thrives in a dynamic, collaborative environment and is passionate about shaping global regulatory strategies. In this role, you’ll work within a dedicated client program, partnering closely with a leading organization to drive high-impact submissions and lifecycle management activities.
This is more than a delivery role—it’s an opportunity to become a trusted advisor, influence strategy, and see your work directly contribute to patient outcomes.
What You’ll Do
• 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
• Perform CMC dossier gap analyses and provide clear, strategic recommendations
• Support and lead global submissions (US, EU, and beyond) from planning through execution
• 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
What You Bring
• 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 (required)
• Strong knowledge of global regulatory requirements (FDA, EMA, and international markets)
• Proven experience in global submission management
• Expertise in authoring/reviewing CMC Modules 1–3 to support variations and performing gap analyses
• A collaborative mindset with strong communication and stakeholder management skills
• Experience with Veeva Vault (RIM/eCTD systems) is a plus
Why You’ll Love This Role
• Dedicated Client Partnership: Build deeper relationships and drive long-term impact—not just project-based work
• Meaningful Work: Contribute to innovative biologics and vaccines that improve patient lives globally
• Global Exposure: Gain experience across US, EU, and international regulatory landscapes
• Growth & Influence: Be seen as a strategic partner and grow your expertise in a high-visibility role
Our Values in Action (Parexel)
We succeed by living our values every day:
• Patient Focus: Everything we do is centered on improving patient outcomes
• Quality & Integrity: We deliver work we’re proud of—accurate, ethical, and compliant
• Respect & Teamwork: We win together through collaboration and trust
• Innovation: We challenge the status quo to solve complex regulatory problems
Ready to Make a Difference?
If you’re looking for a role where your expertise is valued, your voice is heard, and your work truly matters—this is it.
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