Global CMC Quality & Compliance Specialist

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

Job summary

Regeneron Pharmaceuticals, Inc. seeks a Quality representative to manage product and distribution compliance for commercial programs, guiding quality and regulatory elements across the life cycle strategy.

You will collaborate with CMC teams, alliance partners, CMOs and other stakeholders to ensure supply continuity and regulatory alignment. The role supports product quality reviews, regulatory submissions, and launch readiness, with oversight of change management, deviations, CAPAs, and ongoing

Qualifications

• Assoc Specialist requires BS/BA in Chemistry, Biology, or related field with relevant experience, preferably pharma or medical device, including some supervisory/leadership experience.
• Specialist requires BS/BA in Chemistry, Biology, or related field with 2+ years of relevant experience in pharmaceutical or medical device, including some supervisory/leadership experience.
• Sr Specialist requires BS/BA in Chemistry, Biology, or related field with 5+ years of relevant experience in pharmaceutical or medical device, including some supervisory/leadership experience.

Responsibilities

• Oversee the global change management implementation plan.
• Support evaluation of impact of proposed process changes, deviations and CAPAs on end-to-end supply chain.
• Oversee coordination and generation of annual PQRs and yearly biologic product reports (YBPR).
• Assess quality information to detect trends and determine actions needed.
• Ensure drug supply distribution compliance with global regulatory filings.
• 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.
• Develop procedures and systems for tracking change controls and regulatory submissions/approvals.
• Support launch readiness and distribution compliance with GMP documentation and regulatory dossiers.
• Provide writing/strategy support in communications to regulatory agencies.
• Facilitate CARRs process in collaboration with CMC PM, CMC RA, IMT and SMEs.

Education

Assoc Specialist: BS/BA in Chemistry or Biology, with relevant experience, supervisory/leadership

Specialist: BS/BA in Chemistry or Biology, 2+ years Pharmaceutical/Medical device experience, supervisory/leadership

Sr Specialist: BS/BA in Chemistry or Biology, 5+ years Pharmaceutical/Medical device experience, supervisory/leadership

Job description

Regeneron Pharmaceuticals, Inc. seeks a Quality representative to manage product and distribution compliance for commercial programs, guiding quality and regulatory elements across the life cycle strategy.

You will collaborate with CMC teams, alliance partners, CMOs and other stakeholders to ensure supply continuity and regulatory alignment. The role supports product quality reviews, regulatory submissions, and launch readiness, with oversight of change management, deviations, CAPAs, and ongoing