Senior Manager - Regulatory Affairs

Senior Manager, Regulatory Affairs 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. A Senior Manager within R&A provides leadership and direction to consultants, senior consultants and managers, actively managing employee performance and development. A Senior Manager acts as a role model and provides a broad range of consulting services and may be responsible for a specific function/technical area. Key Responsibilities Extensive experience in Regulatory Affairs, including expertise in EU Clinical Trials Regulation (EU CTR) and experience leading and developing teams. Act as the Subject Matter Expert (SME) for the EU Clinical Trials Regulation (EU CTR), providing strategic regulatory guidance and ensuring compliant implementation. Drive capability building within the team through coaching, mentoring, training, and knowledge-sharing initiatives. Contribute to organizational EU CTR-related projects, process improvements, and strategic initiatives. Support the development, review, and maintenance of functional Standard Operating Procedures (SOPs). Provide support during regulatory audits and inspections. Deliver regulatory consultancy and client-focused guidance, fostering strong stakeholder partnerships. Lead and manage a team, ensuring performance, development, and operational excellence. Skills and Competencies Strong expertise in EU Clinical Trials Regulation (EU CTR) and associated regulatory requirements. Ability to interpret regulatory intelligence, assess impact, and translate requirements into practical processes and implementation plans. Solid understanding of regulatory operations, workflows, and compliance standards. Excellent stakeholder management and communication skills, with experience collaborating across global teams and clients. Strong analytical, problem-solving, decision-making, and risk mitigation capabilities in a dynamic environment. Demonstrated ability to work collaboratively and influence cross-functional teams in a consultative manner. Experience Level Senior Level