CMC Quality & Compliance Product Lead

Regeneron Pharmaceuticals, Inc.; United States; Remote; USD 110,000 - 150,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Quality representative to ensure product and distribution compliance for our commercial programs.

You will lead the quality elements of lifecycle strategy, own global regulatory change management, and coordinate end-to-end supply chain improvements with CMC, QA, and manufacturing partners. The role involves overseeing annual PQRs, assessing trends in quality data, supporting regulatory filings during inspections, and ensuring launch readiness with

Qualifications

• Assoc Specialist requires BS/BA in Chemistry, Biology, or related field with relevant experience; supervisory/leadership experience preferred.
• Specialist requires BS/BA in Chemistry, Biology, or related field with 2+ years in pharma/medical device and some supervision/leadership experience.
• Sr Specialist requires BS/BA in Chemistry, Biology, or related field with 5+ years in pharma/medical device and some supervision/leadership experience.

Responsibilities

• Oversee the global change management implementation plan.
• Evaluate impact of proposed process changes, deviations and CAPAs on end-to-end supply chain.
• Coordinate and generate the annual PQRs and yearly biologic product reports.
• Assess quality-related information to detect trends and determine required actions.
• Ensure drug supply distribution compliance with global regulatory filings for stable supply positioning.
• Interact with global regulatory authorities during Agency inspections.
• Collaborate cross-functionally to support regulatory release and inventory review.
• Execute relationship management with Regulatory, Quality, Manufacturing and Supply teams.
• Develop procedures for tracking change controls and regulatory submissions/approvals.
• Support launch readiness and distribution compliance with GMP documentation.
• Provide writing/strategy support for regulatory communications and inspection responses.
• Facilitate CARRs process with CMC PM/RA and SMEs.

Skills

Leadership experience

Regulatory understanding

Quality systems

Education

Assoc Specialist (BS/BA in Chemistry, Biology, or related field)

Specialist (BS/BA in Chemistry, Biology, or related field)

Sr Specialist (BS/BA in Chemistry, Biology, or related field)

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Quality representative to ensure product and distribution compliance for our commercial programs.

You will lead the quality elements of lifecycle strategy, own global regulatory change management, and coordinate end-to-end supply chain improvements with CMC, QA, and manufacturing partners. The role involves overseeing annual PQRs, assessing trends in quality data, supporting regulatory filings during inspections, and ensuring launch readiness with