Associate CMC Product Quality Compliance Specialist

Regeneron Pharmaceuticals

17d • Onsite

About The Position

Regeneron is currently looking for an Associate CMC Product Quality Compliance Specialist to join our Quality Assurance team. This role is responsible for being a Quality representative for product and distribution compliance of Regeneron’s commercial programs. 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 supporting 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. As an Associate CMC Product Quality Compliance Specialist, a typical day might include the following: Provides evaluations and implementation planning to support distribution impactful change controls from all aspects of the business. Works cross-functionally with other quality and CMC teams to support the evaluation of impact of proposed process changes on the end-to-end supply chain. Ensures drug supply distribution compliance with all aspects of global regulatory filings to ensure stable supply positioning. 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. Supports 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.

Requirements

• Excel in a quality driven organization.
• Have an understanding of biologics manufacturing operations.
• Are organized and have an attention to detail.
• Can prioritize multiple assignments and changing priorities.
• Are able to learn and utilize computerized systems for daily performance of tasks.
• To be considered for the Associate CMC Product Quality Compliance Specialist you must be willing and able to work Monday-Friday, 8am-4:30pm.
• You must have a BS/BA in Chemistry, Biology, or related field and 0-2 years of relevant experience.
• May substitute proven experience for education requirement.

Responsibilities

• Provides evaluations and implementation planning to support distribution impactful change controls from all aspects of the business.
• Works cross-functionally with other quality and CMC teams to support the evaluation of impact of proposed process changes on the end-to-end supply chain.
• Ensures drug supply distribution compliance with all aspects of global regulatory filings to ensure stable supply positioning.
• 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.
• Supports 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.

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees