Director – Regulatory Affairs

🔥 16 hours ago

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BBOT

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

BBOT is a biotechnology company developing targeted therapies for cancers driven by RAS signaling and PI3Kα. The company focuses on rational drug design to inhibit the active ON state of RAS and to selectively block RAS-driven PI3K activation, aiming at multiple KRAS mutants and novel approaches to maximize target inhibition. BBOT translates decades of RAS biology research into therapeutic candidates intended to improve outcomes for patients with RAS- and PI3Kα-driven tumors.

📋 Description

• Lead hands-on regulatory submission activities with minimal oversight (Director). • Manage close communication with CROs to ensure on-time submissions and submission tracking. • Partner with Regulatory Operations and Medical Writing to ensure submissions meet global regulatory requirements and are delivered with high quality and on schedule. • Provide strategic regulatory recommendations across nonclinical, CMC, clinical development, companion diagnostics, and lifecycle management activities. • Monitor evolving global regulatory requirements and communicate potential impact on company programs. • Serve as the primary regulatory lead for the assigned program(s). • Lead regulatory planning for major development milestones. • Prepare for regulatory agency meetings, including Type B/C meetings characteristic of early-phase oncology programs.

🎯 Requirements

• Bachelor's degree in Life Sciences, Pharmacy, or a related scientific discipline. • Advanced degree (PharmD, PhD, MS, or equivalent) preferred. • Approximately 10–12 years of regulatory affairs experience within biotechnology or pharmaceutical drug development, including direct experience in oncology drug development. • Demonstrated experience leading regulatory submissions and strategy for oncology development programs, ideally spanning first-in-human through early efficacy stages. • Experience serving as regulatory lead for FDA interactions and major regulatory submissions. • Approximately 14+ years of progressive regulatory affairs experience, including oncology drug development (Senior Director). • Approximately 18+ years of progressive regulatory affairs experience (Executive Director). • Extensive knowledge of FDA, EMA, ICH, and other major global regulatory requirements. • Strong understanding of oncology drug development from First-in-Human through commercialization. • Experience with expedited regulatory pathways (Breakthrough Therapy, Fast Track, Accelerated Approval).

🏖️ Benefits

• base pay • annual performance bonus • company equity • comprehensive health benefits