Senior Regulatory Affairs Leader — FDA Strategy & Submissions

Venesco, LLC; Washington (District of Columbia); On-site; USD 170,000 - 210,000; Full time

Job summary

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. The role emphasizes mentoring, review of development documentation, and leadership in SOP improvements.

A Master’s degree plus RAC and extensive FDA experience are required, with the opportunity to influence regulatory

Qualifications

• 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.

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.

Skills

FDA submissions

Regulatory strategy

Regulatory leadership

Regulatory risk assessment

FDA interactions

Mentoring

SOP improvement

Education

Master's degree in Life Sciences / Pharmacy / Regulatory Affairs

Regulatory Affairs Certification (RAC)

Job description

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. The role emphasizes mentoring, review of development documentation, and leadership in SOP improvements.

A Master’s degree plus RAC and extensive FDA experience are required, with the opportunity to influence regulatory