Compliance Specialist, External Manufacturing
Regeneron Pharmaceuticals
Summary
This role is responsible for operations support and compliance related activities for the manufacturing of Regeneron products.
Job description
Discover your role
- Lead and manage change controls, SCARs, SCN's, NPCs, and CAPAs
- Review and maintain procedures, policies and other instructional documents with a focus on continuous improvement
- Maintain knowledge of current good manufacturing practices (cGMPs)
- Support both internal and external inspection and audit readiness activities
- Responsible for periodic reviews of Drug Product Manufacturing documentation and records to assess for compliance with established quality standards, policies and procedures
- Maintain required training status on Regeneron specific work instructions and SOPs
- Continuous process improvement implementation
This role requires
- BS/BA in scientific field and related experience in cGMP manufacturing operations (clinical and/or commercial)
- Knowledge of drug product manufacturing from formulation through the final package
- Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations
- Proficient in Veeva, Opstrakker, Excel, PowerPoint, Visio, Word, etc. in addition to experience working within shared work environments
- Strong interpersonal, written and oral communication skills, with an emphasis on technical writing
- Exhibits confidence, has a high emotional IQ, and has strong interpersonal, written and oral communication skills for providing team updates
- Shows resiliency and flexibility in the face of challenges and adversarial situations
- Understands and listens to team members and stakeholders needs while supporting productive team environments toward a common objective
- Experience in collaborating with CMOs/CROs is preferred
Requirements
- BS/BA in scientific field
- Related experience in cGMP manufacturing operations
- Knowledge of drug product manufacturing from formulation through final package
- Basic knowledge of regulatory compliance including cGMP, FDA regulations, ICH guidelines, and EU regulations
- Proficient in Veeva, Opstrakker, Excel, PowerPoint, Visio, Word
- Strong interpersonal, written and oral communication skills with emphasis on technical writing
- High emotional IQ
- Resiliency and flexibility in challenging situations
- Ability to understand and listen to team members and stakeholders needs
- Experience collaborating with CMOs/CROs preferred
Benefits
- Annual bonuses
- Incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits
- Paid time off
- Family support benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.