Regeneron · 4 hours ago
Change Control Specialist
Rensselaer, NY
Full-time
Onsite
New Grad, Entry, Mid, Senior Level
$60K/yr - $127K/yr
0+ years expRegeneron is a leading biotechnology company focused on developing innovative medicines. They are seeking a Change Control Specialist to develop strategic plans related to change control and implement corrective actions to support manufacturing operations.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
Craft business plans to independently advances change control initiatives to implement Corrective and Preventative Actions (CAPA’s) and process improvements in support of manufacturing operations
Assess sophisticated proposed change controls to evaluate if proposal satisfies company standards
Coordinate and prepare change control documentation that assesses and defines the scope, impact, risk, and regulatory impact associated with the change
Review, edit, and revise controlled documentation in accordance with cGMP standards
Coordinate and/or lead cross-functional meetings with multiple departments to drive change control implementation
Provide advice and mentorship to cross-functional teams to enable successful and GMP compliant change controls
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
Document all training
Assist with the training of new employees
May manage direct reports
Qualification
Required
Bachelor's degree in Life Sciences, Engineering or related field
0-2 years of relevant experience for Associate Specialist
2+ years of relevant experience for Specialist
5+ years of relevant experience for Sr Specialist
Proven experience may substitute for education requirement
Strong attention to detail
Strong technical writing and interpersonal communication skills
Ability to manage multiple assignments and changing priorities
Robust organizational, planning, and project management skills
Preferred
Experience navigating a controlled quality system
Benefits
Health and wellness programs
Fitness centers
Equity awards
Annual bonuses
Paid time off for eligible employees at all levels
Company
Regeneron
Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.
10001+ employees
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 CompanyTotal Funding
$15.93MKey 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
Aris Baras
Senior Vice President, Regeneron Pharmaceuticals, General Manager, Regeneron Genetics Center
Bari Kowal
Senior Vice President, Head Development Operations & Portfolio Management
Recent News
Pharmaceutical Technology
2025-12-29
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