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 workplace.

- Demonstrated ability to work collaboratively and influence cross-functional teams in a consultative manner.

📌 Senior Manager, Regulatory Affairs (Serilingampalle (M))
🏢 Parexel
📍 Serilingampalle (M)