Mengxin

About Mengxin

Senior Manager in CMC Regulatory Affairs at Regeneron, with nearly a decade of experience bridging science, manufacturing, and global regulatory strategy for advanced therapies. My work has centered on translating technical complexity into clear, executable regulatory pathways—particularly in gene therapy, and other innovative biologics.I’ve had the privilege of leading and supporting multiple global submissions (IND, CTA, BLA), partnering closely with development, QC, and manufacturing teams to align science and compliance. Beyond the technical side, I care deeply about cross-functional collaboration—helping teams find clarity, momentum, and shared purpose in high-pressure environments.What motivates me most is seeing ideas turn into impactful medicines. I’m passionate about thoughtful leadership, mentoring, and building teams where both rigor and empathy can coexist.

Experience

1. Senior Manager, Regulatory Affairs Cmc - New Modalities

   Regeneron

   Apr 2021 — Present

   Assist with the planning, scientific writing and perform critical reviews of INDs, IMPDs, BLAs, MAAs, JNDA, amendments to ensure a high-quality regulatory submission and approval • Lead in planning, organizing and managing the CMC regulatory interactions with global regulatory authorities. • Participate in cross-functional meetings for program-specific discussions, proactively identify CMC regulatory issues and suggest appropriate strategies to mitigate risks • Work with the clinical regulatory and development teams to support regulatory strategy alignment. • Perform the compliance activities of the portfolio to determine regulatory impact and associated submission requirement for clinical and commercial regulatory filings in accordance with country specific regulatory guidance documents. • Demonstrate efficient handling of compliance tasks • Conduct global research to analyze CMC regulatory requirements, define submission pathways for innovative modalities, and provide regulatory support to ensure quality systems addressed expanded scopes.• Ensure regulatory conformance & consistency globally in compliance with regulatory requirements and internal quality procedures • Support establishing, managing and maintaining a knowledge base of current and emerging regulatory requirements and guidelines in the CMC field • Develop and create Working Instructions, SOPs, and/or Reviewer’s Guide to facilitate consistent and efficient practice across the CMC RA units.

Education

• Stony Brook University

  Master of Science (MS), Chemistry

  2014 — 2016

• Southeast University

  Bachelor's degree, Chemistry

  2010 — 2014

• Southeast University

  minor, Business Administration and Management, General

  2010 — 2014

Skills

• Analysis
• Regulatory Submissions
• Leadership
• Gel Electrophoresis
• Uv/Vis
• Food Labelling
• Project Management
• Titration
• Teamwork
• Fda Gmp
• Ir
• Nmr
• Research
• Hplc
• Project Coordination
• Quality Control
• Gmp
• Microsoft Excel
• Powerpoint
• Sop
• Microsoft Word
• Social Media
• Solubility
• Heavy Metals
• Quality Assurance
• Process Validation
• U.s. Food and Drug Administration (Fda)
• Microsoft Office
• Regulatory Affairs
• U.s. Title 21 Cfr Part 11 Regulation
• Management
• Particle Size Analysis
• Electronic Common Technical Document (Ectd)
• U.s. Pharmacopeia (Usp)
• Analytical Method Validation