About Parexel

Parexel is a leading Clinical Research Organization (CRO) and biopharmaceutical consulting company dedicated to advancing patient care through innovative clinical trials, regulatory expertise, and strategic consulting services. With a global presence and deep industry expertise, Parexel partners with biopharmaceutical companies, medical device manufacturers, and government agencies to bring life-changing therapies to patients worldwide. Our mission centers on patient focus, quality and integrity, respect and teamwork, and innovation—values that guide everything we do.

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

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.

Apply now and join our team of dedicated professionals making a real impact in clinical research and patient care.