Job Description
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
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