Senior Manager, Regulatory Affairs

Location: REMOTE, India, Remote

Employment Type: Remote

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.

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