Senior Manager, Regulatory Affairs

Job description

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. #LI-REMOTE