Director / Senior Director / Executive Director, Regulatory Affairs

Description

ABOUT BRIDGEBIO ONCOLOGY THERAPEUTICS

BBOT is a clinical-stage biotechnology company dedicated to developing innovative precision medicines for patients with cancers driven by validated molecular targets. Guided by scientific excellence, operational agility, and an unwavering commitment to patients, BBOT leverages cutting-edge structure-based drug discovery to advance differentiated therapies targeting some of oncology's most challenging pathways, including KRAS and PI3Ka.

Our experienced team of scientists, clinicians, and drug development professionals is committed to bringing transformative therapies to patients with significant unmet medical needs. Headquartered in South San Francisco, our team collaborates across the United States and internationally to rapidly advance our pipeline.

Position Summary

Reporting to the Vice President, Regulatory Affairs, the Director/Senior Director/Executive Director, Regulatory Affairs leads regulatory strategy and submission execution for one or more oncology development programs spanning early through late-stage clinical development and registration.

This role calls for a strategic regulatory thinker who is equally comfortable rolling up their sleeves on submission execution – someone with deep knowledge of global regulatory requirements, a track record leading complex submissions and health authority interactions, and the ability to thrive in a fast-paced, small-company biotechnology environment. The successful candidate will serve as the primary regulatory lead for the assigned program(s), representing Regulatory Affairs on cross-functional development teams.

Requirements

Key Responsibilities

Regulatory Submissions

• Lead hands-on regulatory submission activities with minimal oversight (Director), and provide strategic oversight of submissions led by direct reports and CRO partners (Senior Director/Executive Director).
• Manage close communication with CROs