Compliance Specialist - Process Sciences

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is looking for a Compliance Specialist to join our Global Process Sciences department. This role supports the Process Sciences department by providing oversight of cGMP compliance, with a primary focus on change controls and supplier change notifications. Our team partners across multiple modalities — including bulk drug substance, drug product, combination products, and advanced therapies — giving you broad exposure to Regeneron's diverse pipeline and manufacturing network.

When & where:

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

Discover your role:

• Drive execution and real-time tracking of Process Sciences change controls and supplier change notifications, maintaining accuracy and on-time delivery to support manufacturing operations and regulatory timelines
• Develop strategic plans to support change control implementation of routine program lifecycle management activities, corrective actions, and continuous improvement initiatives
• Evaluate supplier change notifications to determine whether proposed changes meet company standards
• Coordinate and/or lead cross-functional meetings with multiple departments to drive change control implementation
• Serve as the go-to Subject Matter Expert for change control and supplier notification records and systems for Global Process Sciences, championing consistency and rigor across the board
• 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
• Own and communicate key metrics to keep stakeholders informed and aligned

This role requires:

• BS/BA in Life Sciences or related field
  • Associate Compliance Specialist: 0-2 years of experience
  • Compliance Specialist: 2+ years of experience
  • Level will be determined based on experience

Does this sound like you? Apply now to 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.

 

Where necessary, we disclose salary ranges for roles in all countries in which we operate.  The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.  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.

Salary Range (annually)

$62,355.00 - $110,000.00