Principal Scientist (Director) - Regulatory Affairs-CMC
MSDPennsylvania, United States • New Jersey, United States • Cambridge, Massachusetts, United States
Posted April 8, 2026
190800 - 300300 USD
Full Time
About the Company
At MSD, known as Merck & Co., Inc., Rahway, NJ, USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on Facebook, Instagram, Twitter, and YouTube.
Job Description
Principal Scientist / Director, GLOBAL REGULATORY CMC Biologics (R5) responsible for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for biologics product franchises.
Requirements
- Serve as a Regulatory CMC Project Lead
- Lead the development, communication, and review of the CMC Regulatory Strategy Document
- Manage execution of CMC documentation
- Collaborate with partner groups in critical review of submissions
Benefits
- Medical, dental, vision healthcare
- Retirement benefits, including 401(k)
- Paid holidays, vacation, and compassionate and sick days