Manager, Regulatory Intelligence
Posted on Aug 12, 2019 by Covance
Exciting opportunity to work in a global role as Manager, Regulatory Intelligence.
This postion can be based from various Covance locations globally (US, EMEA and APAC locations can be considered - 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.
- University or college degree (life science preferred).
- Professional certification (i.e., Regulatory Affairs, Quality Assurance/Compliance, CRA) or direct experience in Regulatory Intelligence preferred.
- 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.
Covance is an equal opportunity employer and will not discriminate against any employee or applicant for employment because of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.