Senior CMC Regulatory Intelligence Specialist

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a CMC Regulatory Intelligence Specialist (Specialist or Senior Specialist) to join our IOPS Regulatory Sciences team, monitoring and communicating changes in the global CMC regulatory landscape to ensure our manufacturing organization remains in compliance with evolving global requirements. In this role, you will assess regulatory intelligence, facilitate cross-functional working groups, and translate emerging trends and risks into actionable guidance, while collaborating with Regulatory Affairs, Quality, and manufacturing stakeholders across the organization. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

Location: Troy, New York, United States

Work mode: Monday - Friday 8am - 4:30pm

Discover your role:

Monitor and assess global CMC regulatory intelligence for relevance and impact to internal processes, drug development projects, and regulatory strategies; communicate findings effectively to internal stakeholders

Establish working groups, facilitate discussions, and lead presentations that examine emerging regulatory trends and risks, bringing together subject matter experts from across departments and levels to ensure compliance

Collaborate with Regeneron's Global Regulatory Intelligence Department to support public commenting on regulatory drafts and monitor the evaluation and implementation of final CMC regulations and guidelines

Engage with the quality management system to record and track actions required to maintain compliance with new and updated regulatory guidance

Author CMC regulatory intelligence reports and newsletters distributed to the manufacturing organization; provide regulatory intelligence support for queries related to global CMC requirements

Represent Regeneron on industry collaboration forums examining existing and emerging CMC topics, contributing to connected solutions that drive change

Participate in shaping the tools and processes that support regulatory intelligence operations at Regeneron

Strong understanding of global CMC regulations and guidance across major health authorities including FDA and EMA preferred

Excellent written and verbal communication skills with demonstrated ability to synthesize complex regulatory information into clear, actionable narratives for varied audiences

Experience engaging with industry working groups or professional associations a plus

This role requires:

BS/BA in Life Sciences

Specialist: 2+ years of relevant pharmaceutical industry experience

Senior Specialist: 5+ years of relevant pharmaceutical industry experience

May consider equivalent combination of education and experience; level determined based on qualifications

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)

$67,400.00 - $128,700.00