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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.Please 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.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(R).About the RoleWe are seeking a Regulatory Strategy Consultant to join our team in a remote capacity. As a Regulatory Strategy Consultant, you will own regulatory strategy across significant programs and portfolios, providing leadership for major regulatory decisions, authority engagement models, and high-impact submissions. This position plays a key role in advancing clinical development through strategic regulatory planning, lifecycle management, and cross-functional collaboration. You'll work with biopharmaceutical partners to shape regulatory pathways, guide long-range development strategies, and drive submissions that bring new treatments to patients. Responsibilities include leading regulatory strategy development, managing authority engagement, overseeing high-impact submissions, and contributing to long-range development and lifecycle planning.You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through strategic regulatory leadership and advancing clinical research. With diverse teams and continuous learning opportunities, the Regulatory Strategy Consultant can explore career paths and expand expertise across therapeutic areas and development phases.Key ResponsibilitiesOwn and develop regulatory strategy across significant programs or portfolios, ensuring alignment with business objectives and regulatory requirementsProvide leadership on major regulatory decisions, including authority engagement models, submission strategies, and risk mitigation approachesLead the planning and execution of high-impact regulatory submissions, coordinating cross-functional teams and ensuring compliance with regulatory requirementsDevelop and implement long-range development and lifecycle management plans that optimize regulatory pathways and commercial outcomesCollaborate with clinical, scientific, and commercial teams to align regulatory strategy with development timelines and market opportunitiesMonitor regulatory landscape changes and provide strategic recommendations to adapt development and submission approachesCandidate ProfileYou'll thrive in this role if you bring:Strengths in regulatory strategy, strategic planning, and cross-functional leadershipExtensive experience in clinical development, regulatory affairs, or a highly regulated environmentThe ability to lead across teams, influence stakeholders, and communicate complex regulatory concepts clearlyA patient-focused mindset and strong attention to regulatory detail and complianceComfort working with regulatory databases, submission management systems, and collaborative platformsRequired QualificationsBachelor's degree in life sciences, pharmacy, medicine, or related field, or equivalent professional experience10+ years of experience in regulatory affairs, clinical development, or related fieldPrevious experience with vaccine and/or biologic products is requiredDeep knowledge of ICH-GCP, FDA and international regulatory requirements, and clinical trial processesExperience with regulatory tracking systems, electronic submission tools, and clinical development platformsExcellent communication, strategic planning, and problem-solving skills with demonstrated leadership abilityPreferred QualificationsAdvanced degree (M.D., Ph.D., or M.B.A.) or regulatory certification (e.g., RAC) preferredExperience in multiple therapeutic areas or development phasesFamiliarity with global regulatory frameworks and international submission strategiesFluency in additional languages relevant to regulatory submissionsBenefits and CompensationHealth, Vision & Dental InsuranceTuition ReimbursementVacation/Holiday/Sick TimeFlexible Spending & Health Savings AccountsWork/Life Balance401(k) with Company matchPet InsuranceFor a complete list of benefits, please visit www.parexel.com/us-benefits.Some roles may also be eligible for additional incentives, bonuses, or other compensation programs. Our Talent Acquisition team will provide details on applicable bonus plans or incentive structures for eligible positions.We offer a comprehensive benefits package to eligible employees, which includes paid time off, a 401(k) match, life insurance, health insurance, and additional benefit offerings in accordance with the terms of our applicable plans.If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.#LI-LB1EEO 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.
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