Assoc CMC Product Quality Compliance Specialist jobs in United States
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Regeneron · 11 hours ago

Assoc CMC Product Quality Compliance Specialist

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 and supports the development and coordination of quality and compliance elements throughout the product life cycle.

BiopharmaBiotechnologyPharmaceutical
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Comp. & Benefits
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H1B Sponsor Likelynote

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

Qualification

Quality AssuranceRegulatory ComplianceBiologics ManufacturingChange ManagementGMP DocumentationComputerized SystemsAttention to DetailOrganizational Skills

Required

BS/BA in Chemistry, Biology, or related field
0-2 years of relevant experience
Willing and able to work Monday-Friday, 8am-4:30pm
Understanding of biologics manufacturing operations
Ability to prioritize multiple assignments and changing priorities
Organized and have attention to detail
Ability to learn and utilize computerized systems for daily performance of tasks

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)

Company

Regeneron

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Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.

H1B Sponsorship

Regeneron has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (157)
2024 (128)
2023 (128)
2022 (137)
2021 (104)
2020 (122)

Funding

Current Stage
Public Company
Total Funding
$15.93M
Key Investors
U.S. Department of Health & Human Services
2024-07-11Post Ipo Equity· $2.03M
2023-10-18Post Ipo Equity· $5M
2016-08-22Post Ipo Equity· $8.9M

Leadership Team

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Aris Baras
Senior Vice President, Regeneron Pharmaceuticals, General Manager, Regeneron Genetics Center
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Bari Kowal
Senior Vice President, Head Development Operations & Portfolio Management
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Company data provided by crunchbase