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.
#LI-LB1
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com.
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