Regulatory Inspection Readiness Lead

RXinsider LTD.; Cambridge (MA); Hybrid; USD 131,000 - 209,000; Full time

Benefits offered by this job

Healthcare coverage

Well-being resources

Family planning benefits

Generous PTO and holidays

Equity opportunities

Job summary

Moderna, based in Cambridge, MA, seeks a Regulatory Inspection Lead to plan and coordinate regulatory authority inspections (FDA, EMA) across R&D. You will build stakeholder relationships, prepare for inspections, respond to observations, and track CAPAs to closure, contributing to an inspection-ready culture.

You will lead trainings, mock inspections, and development of inspection plans, while partnering with cross-functional teams to ensure compliance and timely regulatory responses in a

Qualifications

• BS/BA, MS or PhD with 6–10+ years in biotech/pharma/clinical research.
• Experience with regulatory inspections and CAPA processes.

Responsibilities

• Builds and maintains relationships with stakeholders in R&D to support compliant inspections.
• Plan and coordinate GCP/GVP/GLP/GCLP inspections.
• Coordinate inspection readiness activities and mock inspections.
• Provide guidance on responses to inspection observations.
• Ensure CAPA are tracked to completion and verified.
• Lead post-inspection lessons learned sessions.
• Maintain inspection management plans and trainings.
• Collaborate on regulatory intelligence programs.
• Contribute to issue management and CAPA tracking.
• Mentor new staff and foster quality culture.

Skills

Inspection coordination

Regulatory intelligence

GxP knowledge

Leadership

Communication

Cross-functional work

Education

BS/BA, MS or PhD in related field

Job description

Moderna, based in Cambridge, MA, seeks a Regulatory Inspection Lead to plan and coordinate regulatory authority inspections (FDA, EMA) across R&D. You will build stakeholder relationships, prepare for inspections, respond to observations, and track CAPAs to closure, contributing to an inspection-ready culture.

You will lead trainings, mock inspections, and development of inspection plans, while partnering with cross-functional teams to ensure compliance and timely regulatory responses in a