Join the Labcorp Quality 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 CLIA, CAP, FDA Device Manufacturing and IVDR?
Please apply if you have 10 years of global regulatory intelligence experience with emphasis on US/Canada/Latin America regulations.
For candidacy, strongly prefer clinical and/or central laboratory knowledge, CLIA, CAP, ISO 15189, ISO 13485, EU IVDR. Experience collaborating with professional groups and regulatory bodies on regulations a plus!
Job Duties:
The Associate Director Regulatory Intelligence monitors the regulatory landscape to ensure current awareness of regulatory updates/changes is maintained across the organization and, where necessary, company procedures are developed or revised to respond to the regulatory changes.
• Support and drive activities to ensure appropriate regulatory intelligence and compliance information is maintained and available across the company.
• Provide regulatory intelligence to the organization, identify potential compliance issues in a timely manner, and ensure they are reported to 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.
• Provide appropriate regulatory compliance information, advice, support and training to project teams and clients, proactively communicating important changes and their potential impact.
• 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, 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 and interact directly with clients on compliance issues
• 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
• Strongly prefer clinical/central laboratory knowledge, CLIA, CAP and EU IVDR
• Experience working with regulatory bodies a plus
• Demonstrated technical knowledge and understanding of global regulatory intelligence and compliance.
• Experience applying GxP requirements to the conduct of drug development.
• 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 a regulated environment with regulatory agencies
• Proven experience in Regulatory Intelligence, project management, and process improvement.
Education/Qualifications/Certifications and Licenses:
• A minimum of Bachelor’s degree in Life Sciences (Or equivalent Life Science experience) *
• Experience may be substituted for education
Application Window: 05/10/25
Pay Range: $120,000 to $140,000/annually and Company Bonus Plan
All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.
Position: This position is Remote with Laboratory visits and travel 25%.
Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here.
Be a part of an exceptional Team!
Labcorp is proud to be an Equal Opportunity Employer:
Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
We encourage all to apply
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