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