QA Associate Director - Regulatory Intelligence

4 days ago

Apply Now

Receive Emails with Similar Jobs

Labcorp

WebsiteLinkedInAll Job Openings

10,000+

💰 Post-IPO Debt on 2019-06

Description

• Join the Quality Department as a Quality Associate Director of Regulatory Intelligence • Monitor the environment for regulatory compliance intelligence • Ensure current awareness is maintained across the organization • Provide regulatory intelligence, identify potential compliance issues and ensure appropriate reporting • Develop targeted summary documents, internal guidance, position papers, training materials and communications • Provide regulatory compliance information, advice, support and training to project teams and clients • Contribute towards the promotion of LabCorp regulatory compliance expertise • Research and evaluate compliance risks and possible solutions • Support client-facing staff on complex regulatory compliance issues • Interact directly with clients on escalated compliance issues

Requirements

• 10 years in regulatory environment (experience in GXP roles) • Strong knowledge of Regulatory Affairs and years of experience in a Regulatory Intelligence position • Demonstrated technical knowledge and understanding of global regulatory intelligence and compliance • Experience applying GxP requirements to the conduct of drug development • Proven ability to deliver consistent project team performance and strategic process improvement initiatives • 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

Benefits

• Medical • Dental • Vision • Life • STD/LTD • 401(k) • Paid Time Off (PTO) or Flexible Time Off (FTO) • Tuition Reimbursement • Employee Stock Purchase Plan