Senior CMC Regulatory Intelligence Specialist

Regeneron Pharmaceuticals

4d•$67,400 - $128,700•Onsite

About The Position

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.

Requirements

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
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

Nice To Haves

Experience engaging with industry working groups or professional associations a plus

Responsibilities

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