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.