Senior Regulatory Affairs Scientist

Venesco • Fort Detrick, MD

5d

About The Position

Venesco LLC is seeking a Senior Regulatory Affairs Scientist to serve as a senior regulatory subject matter expert responsible for developing regulatory strategies, leading FDA interactions, managing submissions, and ensuring compliance throughout the medical product lifecycle.

Requirements

• Master's degree or higher in Life Sciences, Pharmacy, Regulatory Affairs, or related field.
• Regulatory Affairs Certification (RAC) required.
• Minimum 12 years of FDA regulatory affairs experience.
• Extensive experience preparing INDs, NDAs, BLAs, IDEs, and 510(k) submissions.
• Experience interacting directly with FDA review divisions.
• Strong leadership and mentoring experience.

Responsibilities

• Develop regulatory pathways and approval strategies.
• Lead preparation and review of FDA submissions.
• Serve as regulatory lead for assigned programs.
• Provide regulatory risk assessments and mitigation strategies.
• Support FDA meetings and agency interactions.
• Create and maintain Target Product Profiles.
• Monitor regulatory intelligence and emerging requirements.
• Review product development documentation.
• Mentor junior regulatory personnel.
• Lead SOP and process improvement initiatives.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior