Sr. Manager, Regulatory Affairs CDx

Company: Labcorp
Location: Morrisville
Posted on: November 19, 2023

Job Description:

Job DescriptionWe are seeking a Senior Manager Regulatory Affairs to globally support our Companion Diagnostics (CDx) group. Duties will include the following:

• Provides regulatory advice and leadership to CDx and device project teams for the diagnostic, covering all areas from CDx development through approval and launch
• Provides regulatory leadership and input to internal teams involved with IVD/CDx development planning to ensure that the IVD/CDx will meet health authority expectations
• Authors and reviews relevant sections of device regulatory submissions, as appropriate
• Provides guidance to the teams on the regulatory requirements supporting CDx submissions to US FDA and other global health authorities and ensuring that all regulatory submissions are planned, communicated, and executed per regulatory and business requirements
• Collaborates with diagnostic partners to mutually align on co-development regulatory needs and expectations for major project tasks, including regulatory submissions
• Leads and participates in meetings with regulatory agencies in collaboration with diagnostic partners and/or internal teams
• In collaboration with pharmaceutical partners and internal teams, prepares for and executes meetings with regulatory agencies
• Provide interpretation of applicable regulations, guidances, and standards to project teams and clients
• Reviews clinical protocols to assure collection of appropriate data for regulatory submissions and regulatory compliance
• Represents Regulatory Affairs in product life cycle development teams by reviewing, approving, and completing requirements
• Participates in audits as required; oversees follow-up activities and ensures timely implementation and completion of corrective action plans in close cooperation with Quality Assurance
• Contributes to the development and revision of SOPs and standard plans/templates/guidelines to ensure adherence to applicable ethical requirements, regulations, and standards.Education:
  • Bachelor s degree or equivalent in a science, engineering, or related technical field. Advanced degree preferred.Experience:
    • 5 years experience supporting regulatory strategies and supporting FDA or ex-US submissions of in vitro diagnostic (IVD) products, such as with evidence of 510(k)s, and/or PMAs submissions, and/or technical files.
    • Demonstrated experience in one or more phases of IVD product development including design control, regulatory package documentation and GMP manufacturing.
    • Experience and understanding of GxP requirements (GCPs, GLPs, GMPs). Preferred Experience:
      • Experience developing clinical regulatory strategies and/or clinical plans. Comprehensive understanding of GCPs.
      • Experience with drug development, FDA, EMA, IVDR, ex-US, and ICH guidelines.
      • Experience in regulatory environment such as CLIA, CAP, or IVD manufacturing environment.
      • Companion diagnostics experience preferred but not required.
      • Regulatory Affairs Certification (RAC) through Regulatory Affairs Professionals Society (RAPS).Pay Range: $92,405 - $156,006Benefits: 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. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Commissions, and Company bonus where applicable. For more detailed information, please click here. Labcorp is proud to be an Equal Opportunity Employer:As an EOE/AA employer, Labcorp strives for diversity and inclusion 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 of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), 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. We encourage all to apply.For more information about how we collect and store your personal data, please see our Privacy Statement. Associated topics: assistant general manager, assistant gm, district manager, editor in chief, general manager, gerente, manager, police commander, project manager, sergeant

Keywords: Labcorp, Cary , Sr. Manager, Regulatory Affairs CDx, Executive , Morrisville, North Carolina