Exciting opportunity to work in a global role as Manager, Regulatory Intelligence. 

This postion can be based from various Covance locations within EMEA - office or homebased working options.

Working as part of a small team under the direction of the Director, Regulatory Intelligence, duties will include: 

• Maintain knowledge of local regulations, regulatory requirements and industry trends impacting the clinical trials industry;
• Keep Covance staff informed on developments relative to medicinal product and device guidance, directives, regulations and applicable requirements;
• Advise on impact of changes, and support updates of processes and procedural documents as a result of the evolving regulatory environment;
• Coordinate with team, regional and functional representatives in support of identification and implementation of process changes as needed for ensuring alignment with new and evolving regulatory requirements or industry trends/best practices;
• Support client-facing staff as a GCP Subject Matter Expert (SME), providing GCP consultancy in support of compliance queries raised by functional groups;
• Maintain systems and tools in support of Regulatory Intelligence activities;
• Support regulatory authority inspections at Covance facilities.

Qualifications

• University or college degree (life science preferred)
• Professional certification (i.e., Regulatory Affairs, Quality Assurance/Compliance, CRA) or direct experience in Regulatory Intelligence preferred.

Experience

Strong background in Clinical Research in a lead capacity, including a good knowledge of different functions.

Excellent knowledge of GCP. 

Good knowledge and an interest in Regulatory and Quality information.

Experience in Clinical Audits and/or Pharmacovigilance would be an advantage