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. At Parexel, we are a leading Clinical Research Organization (CRO) company specializing in delivering life- changing medicines to patients. We are seeking experienced Senior Regulatory Affairs Consultants / Regulatory Affairs Project Leaders to join our team. As a Senior Regulatory Affairs Consultant / Regulatory Affairs Project Leader you’ll be joining a fast-paced, driven environment that’s helping to make life-changing difference to patients by providing leadership to cross functional regulatory team and managing the day-to-day operations and complexities of preparing and filing NDA and/or BLA applications while ensuring projects are delivered on time, within budget and at the highest quality. Your expertise will contribute to our client’s success and help drive innovation. Who we’re looking for: Detail orientated Regulatory Project Managers with experience overseeing cross-functional teams involved in the creation of US Regulatory Filings i.e. NDAs and/or BLAs. Exceptional experience managing resources and budgets, coordinating team activities, and managing project scheduling. Strong and passionate leaders with the ability to oversee and influence teams. Flexible, focused and calm individuals with the ability to work in a fast-paced environment. Creative problem solvers with the ability to identify risks and present solutions. Excellent communicators who thrive on building strong relationships with internal and external stakeholders. What you’ll do: Oversee and drive multiple regulatory project deliverables and interact with various regulatory SMEs. Monitor and analyze the financial health of your project and take corrective actions. Improve the quality of information being shared (e.g. project estimates, status reports, project forecasts, risks and issues) and ensure that the solution being delivered meets the quality expectations of the key stakeholders. Demonstrate a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced, and objective manner. Additional details: Successful candidates must, at minimum, possess an undergraduate degree in a clinical or health related field: advanced degree preferred, along with at least 10-15 years' experience working in a similar capacity leading US FDA filings within a CRO, Biotech, or a Pharmaceutical Company (previous CRO or Consulting firm experience is highly preferred) The ability to travel 10-15% domestically and/or internationally may be required in the future. Why join us: Be part of groundbreaking projects that are pushing the boundaries of the industry. Experience a collaborative and inclusive work environment that highly appreciates your expertise. Unlock your full potential with professional growth and development opportunities. Enjoy work life balance and flexible working hours. Parexel US Benefits: Health, Vision & Dental Insurance Tuition Reimbursement Vacation/Holiday/Sick Time Flexible Spending & Health Savings Accounts Work/Life Balance 401(k) with Company match Pet Insurance Full list of benefits available here: https://www.parexel.com/us-benefits 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! At Parexel we embrace flexibility and understand that in today’s fast-paced world, employees need to balance their careers with their personal lives. Come join us where learning is constant, and you’re exposed to a world of experiences and open doors. EEO Disclaimer Parexel 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. Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world. We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.