Regulatory Intelligence Associate Director

Join the Labcorp Department as an Associate Director of Regulatory Intelligence!  This is an exciting NEW position at Labcorp! Join an exceptional international organization.

Do you have strong experience in Regulatory Intelligence for a life science company? Do you have knowledge of LDT and IVDR?

Please Apply if you have 10 years in regulatory environment (experience in GXP roles) with Strong knowledge and years of experience in a "Regulatory Intelligence" role. For candidacy, strongly preferred Regulatory Laboratory knowledge, IVD/IVDR, FDA LDT and other compliance guidelines. Experience working with regulators on audits and changes in regulations a plus!

Apply now!

The Associate Director Regulatory Intelligence 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.

Be a part of an exceptional Team!

• 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 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.

• Provides appropriate regulatory compliance information, advice, support and training to project teams and clients, proactively communicating important changes and their potential impact.

• Contributes towards the promotion of LabCorp regulatory compliance expertise, both internally and externally, by collaborating with colleagues and project teams members in support of Labcorp'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 Labcorp 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 Labcorp facilities

Minimum Required:

• Must have 10 years in regulatory environment (experience in GXP roles)

• Must have Strong knowledge and years of experience in a Regulatory Intelligence role

• Leadership experience

• Strong knowledge and years of experience in a "Regulatory Intelligence" role

• Strongly preferred Regulatory Laboratory knowledge, IVD/IVDR, FDA LDT and other compliance guidelines

• Experience working with regulators on audits and changes in regulations a plus

• 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, organizational, 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 disciplines (GxPs)

• Proven experience in the areas of Regulatory Intelligence, project management &

• implementation, compliance, and process improvement.

• Mentor more junior members within the team and organization.