Senior Manager, Regulatory Affairs
Primary Location: India, Remote 求人ID R0000043228 Category Regulatory / Consulting
About this Role
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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