Senior Regulatory Manager

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.