Assoc CMC Product Quality Compliance Specialist

Summary: Responsible for being a Quality representative for product and distribution compliance of Regeneron’s commercial programs including support with the product quality reviews (PQR). This role supports the development, coordination and ownership of the quality and compliance elements of the life cycle strategy, including ownership of the global regulatory change management implementation plan, end-to-end optimization efforts and overseeing product management activities. Works collaboratively with CMC team members, alliance partners, collaborators and CMOs to ensure continuity of supply, consistency within and across programs, supply strategy alignment across functions, and compliance process efficiency.

Essential Duties and Responsibilities may include, but are not limited to, the following:

• 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.