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