Job Description
Putting Patients First-Through Regulatory Excellence At Parexel, we are driven by a single purpose: to help patients get access to life-changing therapies faster. As a Regulatory Affairs Consultant in a dedicated client partnership, you'll play a critical role in making that mission real-guiding complex clinical studies through the regulatory landscape with rigor, insight, and collaboration. This is a high-impact opportunity for a regulatory professional who enjoys ownership, visibility, and close partnership with clients. You'll serve as the primary regulatory expert across multiple clinical studies, working shoulder-to-shoulder with cross-functional teams and client stakeholders to enable compliant, efficient trial execution. If you thrive in a consultative environment, value strong relationships, and want your work to directly support clinical progress, this role offers the best of Parexel: scientific depth, global reach, and true partnership. What You'll Do Regulatory Strategy & Compliance Serve as Regulatory Affairs Lead for 5+ clinical studies within a dedicated client team Provide strategic regulatory guidance to cross-functional study teams navigating complex and evolving global requirements Assess regulatory impact of protocol amendments, informed consent form (ICF) updates, and other study changes Determine whether updates are substantial or non-substantial in accordance with applicable regulations Advise teams on regulatory pathways, processes, and solutions for emerging trial issues Health Authority Engagement Plan, coordinate, and author health authority meeting requests and scientific advice packages, as required Lead preparation and coordination of responses to health authority questions and requests for information Manage regulatory communication strateg