Global CMC Quality & Regulatory Specialist

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

Job summary

Regeneron is seeking a Quality and Regulatory representative to lead product quality reviews and ensure compliance across the life cycle. The role owns global change management, PQRs and regulatory submissions in collaboration with CMC, QA, and manufacturing teams.

You’ll work with alliance partners and CMOs to maintain supply continuity, drive process improvements, and support inspection readiness and regulatory communications. On-site requirements apply in many locations.

Qualifications

• Assoc Specialist requires BS/BA in Chemistry, Biology, or related field with relevant experience or equivalent combination of education and experience.
• Specialist requires BS/BA in Chemistry, Biology, or related field with 2+ years of relevant experience and supervisory/leadership experience or equivalent.
• Sr Specialist requires BS/BA in Chemistry, Biology, or related field with 5+ years of relevant experience and supervisory/leadership experience or equivalent.

Responsibilities

• Oversees the global change management implementation plan.
• Supports the 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 subject matter experts to determine the need for actions required in response to those trends.
• Ensures drug supply distribution compliance with all aspects of global regulatory filings to ensure stable supply positioning.
• Interacts with global regulatory authorities in support of the CMC activities during Agency inspections.
• Collaborates cross-functionally to support regulatory release process and inventory review.
• Executes relationship management with other areas of Regulatory, Quality, Manufacturing, and Supply organizations to support product distribution.
• Develops procedures and systems for enhanced tracking of change controls and global regulatory submissions/approvals.
• Support launch readiness and distribution compliance through ensuring appropriate GMP source documentation is in place to support regulatory activities and launch material is aligned with the applicable regulatory dossiers.
• Responsible for providing writing and strategy support in communications to regulatory agencies including product deviation reports (BPDR, QDR, PDR, etc.), clinical notice of events and agency inspection responses in collaboration with CMC RA, QA, and SMEs as applicable.
• Facilitates the commercial and registration requests (CARRs) process in collaboration with CMC PM, CMC RA, IMT and SMEs as applicable.

Education

Assoc Specialist: BS/BA in Chemistry, Biology, or related field, with relevant experience or equivalent combination of education and experience

Specialist: BS/BA in Chemistry, Biology, or related field, with 2+ years of relevant experience and supervisory/leadership experience or equivalent

Sr Specialist: BS/BA in Chemistry, Biology, or related field, with 5+ years of relevant experience and supervisory/leadership experience or equivalent

Job description

Regeneron is seeking a Quality and Regulatory representative to lead product quality reviews and ensure compliance across the life cycle. The role owns global change management, PQRs and regulatory submissions in collaboration with CMC, QA, and manufacturing teams.

You’ll work with alliance partners and CMOs to maintain supply continuity, drive process improvements, and support inspection readiness and regulatory communications. On-site requirements apply in many locations.