Senior Regulatory Manager

Green Key Resources; Gaithersburg (MD); Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

90% employer contribution toward to-be

20 days PTO with annual increases up t

Wellness program

Summer Friday flexibility

Job summary

Green Key Resources is seeking a highly technical Regulatory Affairs Manager / Senior Manager in Gaithersburg, MD for a 100% hands-on CMC role. The position is hybrid with onsite Tue-Thu.

You will author and coordinate CMC submissions, manage regulatory strategy, and collaborate with global teams and CMOs/CROs. The ideal candidate has a Master’s or PhD with extensive regulatory experience in commercial products and knowledge of FDA, Health Canada, and EMA requirements.

Qualifications

• Master's degree with 10+ years of CMC regulatory affairs experience, or a doctorate with 5+ years.
• Direct CMC submission ownership for commercial products.
• Manufacturing and/or QA/QC experience.
• International regulatory experience with FDA, Health Canada, and EMA requirements.

Responsibilities

• Author and coordinate CMC regulatory submissions and eCTD documentation.
• Manage regulatory strategy, application maintenance, and product lifecycle activities.
• Assess manufacturing, analytical, and quality changes for regulatory impact.
• Partner with health authorities, international teams, and global CMOs/CROs.

Skills

CMC regulatory

Regulatory submissions

eCTD documentation

Regulatory strategy

Global regulatory

Education

Master's degree + 10+ years CMC RA

PhD + 5+ years CMC RA

Job description

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.