QA Assoc Director (Reg Intell)

Job Overview:

Monitors the environment for regulatory compliance intelligence in the company's areas of interest to ensure that current awareness is maintained across the organization and, where necessary, that company procedures are introduced or adapted to respond to changes in the regulatory environment.
  • Supports and drives activities to ensure appropriate regulatory intelligence and compliance information is maintained and made available across the company;
  • Provides regulatory intelligence to the organization, identifies potential compliance issues in a timely manner, and ensures they are reported to the appropriate levels of management in order to achieve satisfactory resolution for the business;
  • Develop targeted summary documents, internal guidance, position papers, training materials and communications to ensure leadership and staff are informed on regulatory compliance information, risks and trends, and how existing procedures might need to be amended to remain in compliance;
  • Provide appropriate regulatory compliance information, advice, support and training to project teams and clients, proactively communicating important changes and their potential impact;
  • Contribute towards the promotion of Covance's regulatory compliance expertise, both internally and externally, by collaborating with colleagues and project teams members in support of Covance's mission, contributing to conference presentations and journal publications, and active participation in appropriate professional bodies;
  • Research and evaluate compliance risks and possible solutions, provide appropriate regulatory compliance information, advice, support and training to project teams and clients, proactively communicating important changes and their potential impact;
  • Promote regulatory compliance expertise, both externally and internally, by collaborating with colleagues and project teams in support of Covance's mission, contributing to conference presentations and journal publications, and actively participating in appropriate professional bodies and regulatory forums;
  • Support client-facing staff by proactively providing advice on complex regulatory compliance issues;
  • Interact directly with clients on compliance issues that are escalated from project teams;
  • Support Regulatory Intelligence and Compliance in proposal discussions and bid defenses;
  • Support regulatory authority inspections at Covance facilities;
  • Perform other duties, as assigned by management


Education/Qualifications:

A minimum of a Bachelor's Degree in Life Sciences preferred (or equivalent Life Science experience)

Experience may be substituted for education.

Experience:

Minimum Required:
  • 10 years in regulatory environment (experience in GXP roles)
  • Demonstrated technical knowledge and understanding of global regulatory intelligence and compliance;
  • Experience applying GxP requirements to the conduct of drug development.
  • Setting priorities for the team about effective planning, organisational, and problem solving skills.
  • Proven ability to deliver consistent project team performance and strategic process improvement initiatives.
  • Lead and encourage team building, influencing and conflict resolution.
  • Proven written, verbal, interpersonal and change management skills.
  • Previous experience working in regulated environments, with regulatory agencies, and with a variety of discliplines (GxPs)
  • Proven experience in the areas of Regulatory Intelligence, project management & implementation, compliance, and process improvement.
  • Mentor more junior members within the team and organisation