Senior Regulatory Manager
Full-time
Green Key Resources
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.
Vacancy posted 1 day ago
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