Senior Regulatory Affairs Scientist

Venesco, LLC; Falls Church (VA); Hybrid; USD 100,000 - 130,000; Full time

Job summary

Venesco, LLC is seeking a Senior Regulatory Affairs Scientist to lead submission strategies and regulatory interactions for innovative medical products. This full-time role offers a hybrid work model based in Falls Church, Virginia.

The ideal candidate will have at least 8 years of regulatory affairs experience and a strong grasp of FDA regulations and ICH guidelines. Responsibilities include developing regulatory strategies and serving as the primary liaison with FDA.

Qualifications

• 8+ years of regulatory affairs experience.
• Strong knowledge of FDA regulations and ICH guidelines.
• RAC certification preferred.

Responsibilities

• Develop and execute regulatory strategies and submission plans.
• Prepare and submit INDs, NDAs, BLAs, and IDEs.
• Serve as primary liaison with FDA and regulatory agencies.
• Provide regulatory guidance to cross-functional teams.
• Monitor regulatory trends and ensure compliance with evolving requirements.
• Review and approve regulatory documentation.

Skills

Regulatory strategies

FDA regulations

Cross-functional collaboration

Education

Advanced degree in regulatory science, biology, or related field

Tools

eCTD

Job description

Description

Senior Regulatory Affairs Scientist

Location: Hybrid
Job Type: Full-Time

About the Role

Join a dynamic regulatory team as a Senior Regulatory Affairs Scientist, where you will lead submission strategies and regulatory interactions for innovative medical products.

Key Responsibilities

• Develop and execute regulatory strategies and submission plans
• Prepare and submit INDs, NDAs, BLAs, and IDEs
• Serve as primary liaison with FDA and regulatory agencies
• Provide regulatory guidance to cross-functional teams
• Monitor regulatory trends and ensure compliance with evolving requirements
• Review and approve regulatory documentation

Requirements

Qualifications

• Advanced degree in regulatory science, biology, or related field
• 8+ years of regulatory affairs experience
• Strong knowledge of FDA regulations and ICH guidelines

Preferred

• RAC certification
• Experience with electronic submissions (eCTD)