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About ParexelParexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.We work with focus, agility, and shared purpose – moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart.About the RoleWe are seeking a Regulatory Strategy Senior Associate to join our team in a remote capacity. As a Regulatory Strategy Senior Associate, you will support regulatory strategy initiatives that advance new treatments for patients. This position plays a key role in regulatory pathway planning, agency engagement support, and strategic compliance oversight. You'll collaborate with cross-functional teams, follow industry-standard processes, and contribute to regulatory strategy from planning through implementation. Responsibilities include developing regulatory pathway recommendations, supporting agency engagement planning, and identifying key risks and opportunities, with opportunities to deepen your expertise and influence regulatory outcomes.You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through strategic regulatory guidance and product development support. With diverse teams and continuous learning opportunities, the Regulatory Strategy Senior Associate can explore career paths and expand skills across regulatory affairs and clinical development.Key ResponsibilitiesDevelop and recommend regulatory pathways for assigned products, studies, or marketsSupport agency engagement planning and prepare materials for regulatory meetingsIdentify key regulatory risks and opportunities to inform development strategyAlign regulatory approaches with development and commercialization objectivesMaintain current knowledge of regulatory requirements and industry guidanceCollaborate with cross-functional teams to ensure regulatory compliance and strategic alignmentPrepare regulatory documentation and submissions as neededTrack regulatory timelines and milestones to support program executionCandidate ProfileYou'll thrive in this role if you bring:Strengths in regulatory strategy, strategic thinking, and problem-solvingExperience working in regulatory affairs, clinical development, or a regulated environmentThe ability to collaborate across teams and communicate clearly with internal and external stakeholdersA patient-focused mindset and strong attention to detailComfort working with regulatory databases, submission tracking systems, and standard office toolsRequired QualificationsBachelor's degree in life sciences, regulatory affairs, pharmacy, or related field, or equivalent professional experience4+ years of experience in regulatory affairs, clinical development, or a related fieldPrevious experience with vaccine and/or biologic products is requiredFDA regulation expertise/knowledge is required and experience with other global markets is preferredKnowledge of ICH-GCP, regulatory requirements, and clinical trial processesExperience with regulatory databases or submission tracking systemsStrong communication, organization, and problem-solving skillsPreferred QualificationsAdvanced degree in regulatory affairs, pharmacy, or related fieldExperience in specific therapeutic areas or development phasesFamiliarity with regulatory submission software or electronic tracking systemsExperience supporting FDA or international regulatory submissionsPlease note - This position is part of a talent pool created in anticipation of future opportunities within our Regulatory team. Candidates may be considered for upcoming roles as business needs evolve.
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