Regulatory Affairs CMC Senior Associate / Consultant - Biologics or Vaccines

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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