Global CMC Quality & Compliance Specialist

Regulatory Jobs; United States; On-site; USD 62,000 - 92,000; Full time

Job summary

Regeneron is seeking a Quality representative to ensure product and distribution compliance for commercial programs. You will lead the quality and regulatory elements across the life cycle, managing global change control, PQRs, and regulatory submissions with CMC RA, QA, and SMEs in collaboration with cross-functional teams.

The role supports launch readiness and distribution compliance by ensuring GMP source documentation aligns with regulatory dossiers and coordinates with regulatory

Qualifications

• BS/BA in Chemistry, Biology, or related field with relevant experience or equivalent combination of education and experience.
• 2+ years of relevant experience in pharmaceutical or medical device, including some supervisory and/or leadership experience (Specialist level).
• 5+ years of relevant experience in pharmaceutical or medical device, including some supervisory and/or leadership experience (Sr Specialist).

Responsibilities

• Oversees the global change management implementation plan.
• Supports evaluation of impact of proposed process changes, deviations and CAPAs on the end-to-end supply chain.
• Oversees the coordination and generation of the annual PQRs and yearly biologic product reports (YBPR).
• Assesses quality-related information to detect trends and works with SMEs to determine actions.
• Ensures drug supply distribution compliance with global regulatory filings for stable supply.

Education

Assoc Specialist

Specialist

Sr Specialist

Job description

Regeneron is seeking a Quality representative to ensure product and distribution compliance for commercial programs. You will lead the quality and regulatory elements across the life cycle, managing global change control, PQRs, and regulatory submissions with CMC RA, QA, and SMEs in collaboration with cross-functional teams.

The role supports launch readiness and distribution compliance by ensuring GMP source documentation aligns with regulatory dossiers and coordinates with regulatory