Senior Regulatory Manager
green key resourcesGaithersburg (MD)
About the role
Regulatory Affairs Manager / Senior Manager Gaithersburg, MD | Hybrid, onsite Tuesday through Thursday Green Key Resources is recruiting for a highly technical, 100% hands on CMC regulatory role focused on commercial stage pharmaceutical products. Join a small company with opportunities to grow and work closely with all departments, including the CEO.
Responsibilities:
Author and coordinate CMC regulatory submissions and eCTD documentation. Manage regulatory strategy, application maintenance, and commercial product lifecycle activities. Assess manufacturing, analytical, and quality changes for regulatory impact. Partner with health authorities, international teams, and global CMOs/CROs.
Requirements:
Master’s degree with 10+ years of CMC regulatory affairs experience, or a doctorate with 5+ years. Previous pharmaceutical experience with commercial products and direct CMC submission ownership. Manufacturing and/or QA/QC experience. International regulatory experience and strong knowledge of FDA, Health Canada, and EMA requirements. Availability for the onsite schedule and occasional travel. Benefits include a 90% employer contribution toward benefits, 20 days of PTO with annual increases up to 30 days, a wellness program, and summer Friday flexibility.
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