Associate CMC Product Quality Compliance Specialist

Regeneron is currently looking for an Associate CMC Product Quality Compliance Specialist to join our Quality Assurance team. This role is responsible for being a Quality representative for product and distribution compliance of Regeneron’s commercial programs. This role supports the development, coordination and ownership of the quality and compliance elements of the life cycle strategy, including ownership of the global regulatory change management implementation plan, end-to-end optimization efforts and supporting product management activities. Works collaboratively with CMC team members, alliance partners, collaborators and CMOs to ensure continuity of supply, consistency within and across programs, supply strategy alignment across functions, and compliance process efficiency.

As an Associate CMC Product Quality Compliance Specialist, a typical day might include the following:

• Provides evaluations and implementation planning to support distribution impactful change controls from all aspects of the business.
• Works cross-functionally with other quality and CMC teams to support the evaluation of impact of proposed process changes on the end-to-end supply chain.
• Ensures drug supply distribution compliance with all aspects of global regulatory filings to ensure stable supply positioning.
• Collaborates cross-functionally to support regulatory release process and inventory review.
• Executes relationship management with other areas of Regulatory, Quality, Manufacturing, and Supply organizations to support product distribution.
• Develops procedures and systems for enhanced tracking of change controls and global regulatory submissions/approvals.
• Supports launch readiness and distribution compliance through ensuring appropriate GMP source documentation is in place to support regulatory activities and launch material is aligned with the applicable regulatory dossiers.

This role might be for you if you:

• Excel in a quality driven organization.
• Have an understanding of biologics manufacturing operations.
• Are organized and have an attention to detail.
• Can prioritize multiple assignments and changing priorities.
• Are able to learn and utilize computerized systems for daily performance of tasks.

To be considered for the Associate CMC Product Quality Compliance Specialist you must be willing and able to work Monday-Friday, 8am-4:30pm. You must have a BS/BA in Chemistry, Biology, or related field and 0-2 years of relevant experience. May substitute proven experience for education requirement.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)