Vice President - Regulatory

October 25

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Arsenal Biosciences, Inc.

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Biotechnology • technology • artificial intelligence • cancer • immunology

201 - 500 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🔥 Funding within the last year

💰 Series C on 2024-09

Description

• Arsenal Biosciences Inc. is a clinical-stage company engineering CAR T-cell therapies for solid tumors • Seeking a Vice President, Regulatory to work remotely • Spearhead all regulatory affairs for drug product development • Drive clinical and CMC regulatory strategies • Ensure compliance while advancing innovative therapies through the approval process • Provide leadership to the Regulatory team

Requirements

• Minimum of a Bachelor's degree in biological, pharmaceutical, chemical or engineering sciences • 15+ years of experience, with at least 10+ years in regulatory affairs • Knowledge of EU and FDA regulations • Experience in filing regulatory submissions from early development to post-approval • Strong knowledge of eCTD elements and regulatory writing skills • Demonstrated knowledge of regulatory requirements in clinical trials • Experience with regulations in gene therapy, such as CAR-Ts, AAVs, or CRISPR • Demonstrated enterprise leadership skills

Benefits

• Medical, dental, and vision benefits • Mental health resources • Virtual and telehealth options • Coaching • Infertility treatment • Parental leave • Health savings accounts • Flexible work schedules • Flexible time off • Two extra “Arsenal Days of Rest” every quarter