Compliance Specialist, External Manufacturing

Regeneron Pharmaceuticals, Inc.; United States; On-site; USD 62,000 - 129,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Compliance Specialist to support External Manufacturing operations in East Greenbush, NY. The role focuses on ensuring cGMP compliance, maintaining procedures, and preparing for inspections, while driving continuous improvement.

The position requires knowledge of FDA/ICH regulations, experience with CMOs/CROs, and strong writing and communication skills. On-site work schedule is Monday–Friday, 8am–4:30pm.

Qualifications

• BS/BA in scientific field required with cGMP operations experience.
• Knowledge of regulatory compliance (cGMP, FDA, ICH, EU).
• Experience with CMOs/CROs preferred.
• Strong written and verbal communication skills.

Responsibilities

• Lead and manage change controls, SCARs, SCNs, NPCs, and CAPAs.
• Review and maintain procedures and other documents with a focus on continuous improvement.
• Maintain knowledge of current good manufacturing practices (cGMPs).
• Support internal and external inspection and audit readiness activities.
• Perform periodic reviews of Drug Product Manufacturing documentation for compliance with quality standards.

Skills

Interpersonal skills

Communication skills

Technical writing

Adaptability

Team collaboration

Education

BS/BA in scientific field

Tools

Veeva

Opstrakker

Excel

PowerPoint

Visio

Word

Job description

Build our future together

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking to fill a Compliance Specialist position within the External Manufacturing team. This role is responsible for operations support and compliance related activities for the manufacturing of Regeneron products.

When & where:

Location: East Greenbush, New York, United States
Work schedule: Monday-Friday, 8am-4:30pm

Discover your role:

• Lead and manage change controls, SCARs, SCN's, NPCs, and CAPAs
• Review and maintain procedures, polices 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 the following amount of related experience in cGMP manufacturing operations (clinical and/or commercial for each level: Associate Specialist - 0-2 years Specialist - 2+ years Sr Specialist - 5+ years Level will be determined based on experience)
• 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

Does this sound like you? take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Salary Range (annually)
$62,355.00 - $128,700.00

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.