Senior Regulatory Affairs Lead: FDA Submissions & Strategy

Venesco, LLC; Falls Church (VA); Ibrido; USD 100.000 - 130.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

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

Mansioni

• 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.

Conoscenze

Regulatory strategies

FDA regulations

Cross-functional collaboration

Formazione

Advanced degree in regulatory science, biology, or related field

Strumenti

eCTD

Descrizione del lavoro

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.