Compliance Specialist - Process Sciences

Regeneron Pharmaceuticals•Valley, AL

9d•$62,355 - $110,000•Onsite

About The Position

This role supports the Process Sciences department by providing oversight of cGMP compliance, with a primary focus on change controls and supplier change notifications. Our team partners across multiple modalities — including bulk drug substance, drug product, combination products, and advanced therapies — giving you broad exposure to Regeneron's diverse pipeline and manufacturing network.

Requirements

BS/BA in Life Sciences or related field
Associate Compliance Specialist: 0-2 years of experience
Compliance Specialist: 2+ years of experience
Level will be determined based on experience

Responsibilities

Drive execution and real-time tracking of Process Sciences change controls and supplier change notifications, maintaining accuracy and on-time delivery to support manufacturing operations and regulatory timelines
Develop strategic plans to support change control implementation of routine program lifecycle management activities, corrective actions, and continuous improvement initiatives
Evaluate supplier change notifications to determine whether proposed changes meet company standards
Coordinate and/or lead cross-functional meetings with multiple departments to drive change control implementation
Serve as the go-to Subject Matter Expert for change control and supplier notification records and systems for Global Process Sciences, championing consistency and rigor across the board
Independently monitor and progress multiple projects concurrently – identifying, addressing, and/or raising potential obstacles in a timely manner
Present business critical and regulatory impactful change controls to senior leadership
Own and communicate key metrics to keep stakeholders informed and aligned