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Job Description
Regeneron seeks an Associate Compliance Specialist-External Manufacturing to support operations and compliance activities for the manufacture of Regeneron products.
This is a temporary 12-month contract position.
Key Responsibilities:
- Lead and manage deviation investigations, CAPAs, and change controls
- Review and maintain procedures, policies, and instructional documents for continuous improvement
- Generate and track performance metrics
- Maintain knowledge of current good manufacturing practices (cGMPs)
- Complete periodic reviews of External Manufacturing documentation and records for compliance with established quality standards
- Travel to contract manufacturers or business partners (25% or less)
- Maintain training status on Regeneron-specific work instructions and SOPs
- Assist in maintaining product integrity and company reputation by monitoring cGMP compliance at External Manufacturing contract manufacturers
- Implement continuous process improvements
Requirements:
- BS/BA in a scientific discipline
- 0-2 years' experience
- Strong understanding of External Manufacturing from formulation through final package
- Regulatory compliance knowledge, including cGMP, FDA regulations, ICH guidelines, and EU regulations
- Proficiency in Excel, PowerPoint, Visio, Word, etc.
- Excellent communication, interpersonal, and written skills
- Ability to work in a shared work environment
- Experience collaborating with CMOs/CROs
Regeneron is an equal opportunity employer and provides comprehensive benefits, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees.
Regeneron is committed to diversity and inclusion and will provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment.
Salary ranges are shown in accordance with applicable laws and regulations.