Regulatory Intelligence Associate Director
Job ID: 2425796
Category: Regulatory/Compliance
Location: Remote, United States
Job Type: Full-Time
Remote: Yes
About the Role
Labcorp is seeking an experienced Regulatory Intelligence Associate Director to join its team. This new position offers an exciting opportunity to contribute to Labcorp’s mission in a global organization, ensuring that regulatory intelligence and compliance are effectively maintained across the company. This is a remote role with occasional travel to laboratory facilities (25%).
Key Responsibilities
Monitor the regulatory environment for compliance intelligence and ensure the organization stays up to date with the latest changes.
Provide regulatory intelligence and compliance information, identify potential compliance issues, and ensure they are reported and addressed effectively.
Develop targeted summary documents, internal guidance, training materials, and communication to inform leadership and staff of compliance risks, trends, and necessary changes to remain compliant.
Advise project teams and clients on regulatory compliance issues, proactively communicating important regulatory changes and their potential impact.
Collaborate with colleagues and project teams to contribute to Labcorp’s regulatory expertise, participate in conference presentations, journal publications, and professional bodies.
Provide regulatory support and advice to client-facing staff, helping them with complex compliance issues escalated from project teams.
Support regulatory inspections at Labcorp facilities.
Contribute to proposal discussions and bid defenses related to Regulatory Intelligence and Compliance.
Minimum Required Qualifications
10+ years of experience in a regulatory environment (GXP roles).
Strong experience in Regulatory Intelligence and compliance roles.
Leadership experience and ability to guide teams.
In-depth knowledge of Regulatory Laboratory practices, IVD/IVDR, FDA LDT, and compliance guidelines.
Experience with regulatory audits and regulatory changes is highly preferred.
Demonstrated technical knowledge of global regulatory intelligence and compliance.
Ability to apply GxP requirements to drug development.
Proven skills in project management, strategic process improvement, team leadership, and conflict resolution.
Excellent written, verbal, interpersonal, and change management skills.
Education/Qualifications
Minimum of a Bachelor’s degree in Life Sciences (or equivalent Life Science experience).
Experience may substitute for education.
Compensation and Benefits
Pay Range: $120,000 to $140,000 annually, plus company bonus plan.
Comprehensive benefits for employees working 20+ hours per week, including Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO), Tuition Reimbursement, and Employee Stock Purchase Plan.
Labcorp is an Equal Opportunity Employer
Labcorp values diversity and inclusion in the workforce, and all qualified applicants will be considered for employment without regard to race, religion, color, national origin, gender, family status, or other protected characteristics.
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