Product Quality Compliance Specialist (CMC)

Regeneron Pharmaceuticals

11d • $67,400 - $110,000 • Onsite

About The Position

Regeneron is seeking a Product Quality Compliance Specialist to support Chemistry, Manufacturing, and Controls (CMC) activities. The role serves as a quality representative for product and distribution compliance across commercial programs, including product quality reviews (PQRs). It supports development, coordination, and ownership of quality and compliance elements of the product life-cycle strategy, including the global regulatory change management implementation plan, end-to-end optimization, and product management activities. The specialist works with CMC team members, alliance partners, collaborators, and contract manufacturing organizations to support continuity of supply, program consistency, cross-functional supply strategy alignment, and efficient compliance processes.

The position is based in Rensselaer, New York, and follows a Monday–Friday schedule from 8:00 AM to 4:30 PM. The level—Associate QA Specialist, Specialist, or Senior Specialist—is determined based on qualifications relevant to the role.

Requirements

• Bachelor’s degree in Chemistry, Biology, or a related field.
• Associate QA Specialist level: 0–2 years of relevant experience, or an equivalent combination of education and experience; pharmaceutical or medical device experience is preferred.
• Specialist level: At least 2 years of relevant pharmaceutical or medical device experience, or an equivalent combination of education and experience.
• Senior Specialist level: At least 5 years of relevant pharmaceutical or medical device experience, or an equivalent combination of education and experience.
• Relevant experience may include supervisory and/or leadership experience.
• Work schedule is Monday–Friday, 8:00 AM–4:30 PM.

Nice To Haves

• Pharmaceutical or medical device experience for the Associate QA Specialist level.

Responsibilities

• Oversee the global change management implementation plan.
• Support evaluation of the impact of proposed process changes, deviations, and CAPAs on the end-to-end supply chain.
• Oversee coordination and generation of annual product quality reviews (PQRs) and yearly biologic product reports (YBPRs).
• Assess quality-related information to detect trends and work with subject matter experts to determine appropriate actions.
• Ensure drug supply distribution complies with global regulatory filings to support stable supply positioning.
• Interact with global regulatory authorities in support of CMC activities during agency inspections.
• Collaborate cross-functionally to support the regulatory release process and inventory review.
• Manage relationships with Regulatory, Quality, Manufacturing, and Supply organizations to support product distribution.
• Develop procedures and systems to improve tracking of change controls and global regulatory submissions and approvals.
• Support launch readiness and distribution compliance by ensuring appropriate GMP source documentation is available for regulatory activities and launch materials align with applicable regulatory dossiers.
• Provide writing and strategy support for communications to regulatory agencies, including product deviation reports, clinical notices of events, and agency inspection responses, in collaboration with CMC RA, QA, and subject matter experts.
• Facilitate the commercial and registration requests (CARRs) process in collaboration with CMC PM, CMC RA, IMT, and subject matter experts.

Benefits

• Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level