Remote Regulatory CMC Specialist, Chemistry & Controls

Medexus Pharmaceuticals, Inc. · Workfromhome, United States

Medexus Pharmaceuticals Inc. seeks a Senior Specialist, Regulatory CMC to manage change controls and regulatory work for U.S. and Canadian products and oversee post-approval submissions.

You will assess changes, determine regulatory pathways, prepare updates, and coordinate documentation with internal teams and external partners. Reporting to the Senior Director, Regulatory Affairs & Pharmacovigilance, you will lead multiple CMC changes, monitor FDA and Health Canada requirements, and support