Director, Regulatory Affairs – Oncology (Equity)

BridgeBio Oncology Therapeutics; United States; On-site; USD 210,000 - 275,000; Full time

Job summary

BridgeBio Oncology Therapeutics seeks a Director/Senior Director/Executive Director, Regulatory Affairs to lead regulatory strategy and submission execution for oncology development programs from early through late-stage development and registration. This role requires deep regulatory knowledge, hands-on submission execution, and collaboration across cross-functional teams.

The successful candidate will represent Regulatory Affairs on development teams, manage interactions with FDA and global

Qualifications

• Extensive knowledge of FDA/EMA/ICH requirements.
• Experience leading regulatory submissions for oncology programs.
• Experience with FDA interactions and major submissions.

Responsibilities

• Lead regulatory submission activities with strategic oversight.
• Develop and execute global regulatory strategies for oncology programs.
• Provide regulatory leadership on cross-functional teams.
• Prepare for health authority meetings and responses.

Skills

Regulatory strategy

Regulatory submissions

Health authority interactions

Leadership & mentoring

Global compliance knowledge

Excellent communication

Education

Bachelor's in Life Sciences

Advanced degree preferred

Job description

BridgeBio Oncology Therapeutics seeks a Director/Senior Director/Executive Director, Regulatory Affairs to lead regulatory strategy and submission execution for oncology development programs from early through late-stage development and registration. This role requires deep regulatory knowledge, hands-on submission execution, and collaboration across cross-functional teams.

The successful candidate will represent Regulatory Affairs on development teams, manage interactions with FDA and global