Regulatory Affairs Consultant - Clinical Regulatory Affairs

Putting Patients First-Through Regulatory ExcellenceAt 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 & ComplianceServe as Regulatory Affairs Lead for 5+ clinical studies within a dedicated client teamProvide strategic regulatory guidance to cross-functional study teams navigating complex and evolving global requirementsAssess regulatory impact of protocol amendments, informed consent form (ICF) updates, and other study changesDetermine whether updates are substantial or non-substantial in accordance with applicable regulationsAdvise teams on regulatory pathways, processes, and solutions for emerging trial issuesHealth Authority EngagementPlan, coordinate, and author health authority meeting requests and scientific advice packages, as requiredLead preparation and coordination of responses to health authority questions and requests for informationManage regulatory communication strategy for assigned studiesEnsure timely and compliant submission of annual reports and safety updatesStakeholder Partnership & CommunicationParticipate in regular study team meetings to track trial progress and proactively surface regulatory considerationsProvide clear and accurate updates to client management on regulatory status, risks, and upcoming milestonesAct as the primary regulatory point of contact for study teams and client stakeholdersDocumentation & Project ManagementMaintain accurate, current regulatory tracking systems in accordance with Parexel and client standardsEnsure all regulatory documentation meets quality expectations and agreed timelinesSupport ad hoc study needs and contribute to continuous improvement and departmental initiativesTo Ensure Success, You'll HaveAt least 5 years of regulatory affairs experience to include previous clinical regulatory affairs experienceA minimum of a bachelor's degree in a scientific or technical discipline, advanced degree strongly preferredKnowledge of FDA Regulations and previous experience with FDA meeting requests and other packages. Experience with other global Health Authorities and applicable regulations are strongly preferredProject management / leadership experienceExcellent interpersonal and intercultural communication skills, both written and verbalClient-focused approach to work (Quality)Results orientationTeamwork and collaboration skillsConsulting skillsCritical thinking and problem-solving skillsProficiency in local language and extensive working knowledge of the English languageWhy Join Parexel?Work in a dedicated partnership model with strong client trust and visibilityBe part of a global organization known for regulatory leadership and scientific excellenceCollaborate with talented, purpose-driven colleagues across functions and regionsMake a meaningful contribution to clinical programs that put patients first#LI-LB1#LI-REMOTEEEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.