QA Associate Director, Regulatory Intelligence
About the position
Responsibilities
• Monitor the regulatory environment for compliance intelligence and ensure awareness across the organization.
• Provide regulatory intelligence and identify potential compliance issues, reporting them to management for resolution.
• Develop summary documents, internal guidance, position papers, and training materials on regulatory compliance information.
• Communicate important regulatory changes and their potential impact to project teams and clients.
• Promote Labcorp's regulatory compliance expertise through collaboration and participation in professional bodies.
• Research and evaluate compliance risks and provide solutions and training to project teams and clients.
• Support client-facing staff with advice on complex regulatory compliance issues.
• Interact with clients on escalated compliance issues from project teams.
• Support regulatory authority inspections at Labcorp facilities.
Requirements
• 10 years of experience in a regulatory environment, particularly in GXP roles.
• Strong knowledge of Regulatory Affairs and experience in a Regulatory Intelligence position.
• Demonstrated technical knowledge of global regulatory intelligence and compliance.
• Experience applying GxP requirements in drug development.
• Strong planning, organizational, and problem-solving skills.
• Proven ability to deliver project team performance and process improvement initiatives.
• Experience in team building, influencing, and conflict resolution.
• Excellent written, verbal, interpersonal, and change management skills.
• Experience working in regulated environments and with regulatory agencies.
Nice-to-haves
• Experience mentoring junior team members.
• Previous experience in project management and implementation.
Benefits
• Medical
• Dental
• Vision
• Life Insurance
• Short-Term Disability/Long-Term Disability
• 401(k)
• Paid Time Off (PTO) or Flexible Time Off (FTO)
• Tuition Reimbursement
• Employee Stock Purchase Plan
Apply Now
Apply Now
Responsibilities
• Monitor the regulatory environment for compliance intelligence and ensure awareness across the organization.
• Provide regulatory intelligence and identify potential compliance issues, reporting them to management for resolution.
• Develop summary documents, internal guidance, position papers, and training materials on regulatory compliance information.
• Communicate important regulatory changes and their potential impact to project teams and clients.
• Promote Labcorp's regulatory compliance expertise through collaboration and participation in professional bodies.
• Research and evaluate compliance risks and provide solutions and training to project teams and clients.
• Support client-facing staff with advice on complex regulatory compliance issues.
• Interact with clients on escalated compliance issues from project teams.
• Support regulatory authority inspections at Labcorp facilities.
Requirements
• 10 years of experience in a regulatory environment, particularly in GXP roles.
• Strong knowledge of Regulatory Affairs and experience in a Regulatory Intelligence position.
• Demonstrated technical knowledge of global regulatory intelligence and compliance.
• Experience applying GxP requirements in drug development.
• Strong planning, organizational, and problem-solving skills.
• Proven ability to deliver project team performance and process improvement initiatives.
• Experience in team building, influencing, and conflict resolution.
• Excellent written, verbal, interpersonal, and change management skills.
• Experience working in regulated environments and with regulatory agencies.
Nice-to-haves
• Experience mentoring junior team members.
• Previous experience in project management and implementation.
Benefits
• Medical
• Dental
• Vision
• Life Insurance
• Short-Term Disability/Long-Term Disability
• 401(k)
• Paid Time Off (PTO) or Flexible Time Off (FTO)
• Tuition Reimbursement
• Employee Stock Purchase Plan
Apply Now
Apply Now