Senior Regulatory Affairs Consultant - (Post Approval CMC Authoring - Vaccines or Biologics)
parexel · Canada-Ontario-Remote ·
- Work mode
- Remote
- Seniority
- Senior
- Category
- Legal
- Experience
- 5+ years
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
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 / Regulatory Affairs 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 across both development and commercial products.
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 global CMC regulatory strategies for commercial biologics and vaccine products
Support and drive post-approval regulatory activities, including variations, supplements, manufacturing changes, CMC changes, lifecycle maintenance, and health authority commitments
Author and review high-quality CMC documentation (Modules 1-3) for global submissions
Perform CMC dossier gap analyses and provide clear, strategic recommendations
Lead and support global submissions (US, EU, and international markets) from planning through execution
Partner cross-functionally with Regulatory Affairs, Quality, Manufacturing, Supply Chain, Technical Operations, and client stakeholders
Assess regulatory impact of product, process, manufacturing, analytical, and control strategy changes
Act as a key contributor within a dedicated client team, building strong, trusted relationships
Ensure submissions meet global regulatory expectations with precision, quality, and compliance
What You'll Bring
Required Qualifications
5+ years of experience in CMC Regulatory Affairs or CMC Strategy for a Regulatory Affairs Consultant role; 7+ years for a Senior Regulatory Affairs Consultant role
Demonstrated post-approval CMC regulatory experience supporting commercial biologics and/or vaccines (required)
Hands-on experience managing lifecycle maintenance activities for approved biologic and/or vaccine products, including one or more of the following:
Post-approval supplements
Variations
Manufacturing changes
Process changes
Analytical method updates
Site transfers
Specification changes
Health authority commitments
Labeling-related CMC changes
Strong knowledge of global regulatory requirements, including FDA, EMA, and international markets
Proven experience supporting global submission strategy and execution
Expertise authoring and reviewing CMC Modules
Experience performing CMC dossier assessments and gap analyses
Strong communication, collaboration, and stakeholder management skills
Ability to work directly with clients and cross-functional teams in a highly matrixed environment
Preferred Qualifications
Experience supporting both clinical development and commercial lifecycle management activities
Experience with vaccines, biologics, monoclonal antibodies, recombinant proteins, gene therapies, or other advanced biologic modalities
Experience with Veeva Vault RIM, eCTD publishing, and regulatory information management systems
Advanced scientific degree (MS, PhD, PharmD, or equivalent)
Why You'll Love This Role
Dedicated Client Partnership
Build deeper relationships and drive long-term impact through a strategic partnership rather than 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 while supporting global product portfolios.
Growth & Influence
Be recognized as a strategic regulatory partner while expanding your expertise in biologics, vaccines, and post-approval CMC strategy.
Ready to Make a Difference?
If you have experience supporting approved biologic and/or vaccine products through post-approval regulatory submissions and lifecycle management activities and are looking for a role where your expertise is valued, your voice is heard, and your work truly matters, we'd love to hear from you.
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