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.
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.
