Senior Regulatory Affairs Consultant - (Post Approval CMC Authoring - Vaccines o

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, anal