LinkedIn ShareShare
More

Description:

Manager, Regulatory Compliance (GCP)

Full time contract role; 12 months

 

Job Responsibilities and skills:

Auditor:

  • Lead investigator site audits, and is responsible for the preparation and reporting of such.
  • Support for and regulatory agency inspections of investigator sites. Assists in the coordination of responses to any regulatory agency findings.
  • Participate in internal audits, may be required to lead.

General:

  • Fosters a commitment to quality in individuals and a culture of quality within the organization.
  • Work is performed under limited supervision. Minimal instruction is required only occasionally. Establishes and implements new tools as necessary.
  • Manages both routine and complex audit activities involving multiple projects and is responsible for ensuring activities are completed.
  • Evaluates departmental and business area SOPs for fit for purpose and in compliance with regulatory requirements.
  • Purpose is for input and obtaining information for dissemination intra- or interdepartmentally.
  • Considers a number of factors in planning, anticipate work and prioritize work to meet tight timelines.
  • Effectively delivers messages to all audiences.
  • Considers needs and level of audience in communication.
  • Uses logical persuasion in discussions and presentations.
  • Determines efficient and appropriate method of communication.
  • Understands impact of decisions and actions on business and consults with appropriate colleagues and management as applicable
  • Promotes and maintains productive working relationships.
  • Must have an in depth knowledge of regulatory requirements for assigned territories.
  • Is recognised as a knowledgeable resource within the department and from other departments on a range of topics and someone whose opinion is sought as a regulatory resource.
  • Understands current global and regional trends in regulatory compliance.

To learn more about this role, please apply or contact Paul directly on paul.shaw@bluepelican.com

How to apply

If this position is of interest please send us your CV here, or you can call Paul Shaw direct on to discuss this and other vacancies that may suit.

Paul Shaw

Email: paul.shaw@bluepelican.com