Senior Manager, Regulatory Affairs

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.

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.