Associate Director/Director, Regulatory Affairs - BBOT

BridgeBio Oncology Therapeutics (BBOT) is a clinical-stage biopharmaceutical company advancing a next generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies. Initially formed as a subsidiary of BridgeBio Services, BBOT completed a $200M private financing with external investors in 2024 with the goal of improving outcomes for patients with cancers driven by the two most prevalent oncogenes in human tumors.

For more information visit bridgebiooncology.com.

Responsibilities

The Associate Director/Director, Regulatory Affairs for BridgeBio Oncology Therapeutics will be a strategic thinker responsible for overseeing (with support) the regulatory assessment and research on regulatory precedence to evaluate regulatory strategies for development programs focused on precision medicine. 

This individual will also be responsible for application maintenance activities, amendments/supplements, and other policies and procedures as assigned. This position will be part of a high-performing regulatory team working across the Oncology space within BBOT. The individual for this role will have collaborative and leadership skills to allow for successful cross-functional interactions within the BBOT organization.

As a key member of the Regulatory Affairs team, you will: 

• Manage regulatory communication with regulators (globally) as assigned, including submission correspondence, and assist/lead with informal and formal agency meetings, responses to Agency requests, and pre-meeting packages.
• Ensure effective timeline management for preparing and reviewing submissions and applications, including ODD, BTD, CTAs, INDs, NDAs, MAA, and all equivalent submissions globally within the established timelines. 
• Maintain all regulatory applications to ensure compliance with regulations, including the preparation, review, and execution of pre- and post-marketing submission activities. 
• Assist regulatory teams by leading and advising cross- functional teams on assigned regulatory strategies that optimize and expedite development. 
• As a regulatory representative on assigned drug project teams, the incumbent will provide regulatory guidance and recommendations to the cross-functional teams that align with the company goals, international laws and regulations, and the overall regulatory strategy and implementation of the product development plan.
• Manage coordination with the Regulatory Operations Team. (publishers) for assigned submissions to Agencies to ensure proper direction, preparation, and quality Q.C. is performed and that all submissions are timely and compliant with all Agency laws. 
• Conduct frequent Regulatory Intelligence related to the assigned programs and disseminate relevant information to senior management and cross functional teams. 
• Work with Regulatory Affairs leadership to review and approve promotional and non-promotional materials.
• Assist with all regulatory business development efforts as needed.

Education, Experience & Skills Requirements

• Advanced degree or B.S. Degree in a science-related field.
• Minimum 8 years for Associate Director level and 10+ years for Director level of experience within regulatory affairs environment (Preferably in  oncology) in pharmaceutical/biologics.
• Experience with leading, preparing, and submitting successful submissions, preferably U.S. and E.U. marketing application submission experience.
• Direct experience with FDA regulations relating to advertising and promotion for prescription products and/or product development process,  including labeling development process, a plus.
• Ability to analyze and interpret scientific data and regulations to apply to an oncology program.
• Evidence of being a critical strategic thinker who is solution- oriented with the ability to think outside of the box; preference for demonstration of such within oncology programs.
• Ability to prioritize multiple urgent priorities and experience with wearing multiple hats; management of non- regulatory functional activities is preferred.
• Thorough understanding and demonstrated experience with eCTD submission requirements, utilizing document templates, and knowledge of global operational regulations and guidelines.
• Excellent written and oral communication skills· Demonstrated influencing and leadership skills.
• Fluent with Microsoft Office (Word, Excel, PowerPoint) and Adobe Acrobat (PDF) rendering software.
• Work Environment: Remote Position