Senior Director, Global Regulatory Affairs
San Diego, CA Hybrid
$240,000–$275,000 a yearJobFig found this opening at its original source and checks that it remains available.
About the role
The Senior Director, Global Regulatory Affairs will provide strategic regulatory leadership across Janux’s clinical-stage oncology pipeline, supporting programs from early development through registration. This individual will lead global regulatory strategy for one or more programs while influencing and partnering closely with cross-functional stakeholders to shape development plans and ensuring alignment across functions in a dynamic, fast-paced environment. This role requires a hands-on regulatory leader with deep experience in early clinical development (Phase 1/2), coordinating multiple parallel regulatory initiatives, strong health authority interaction experience, the ability to exercise judgment with decisions that have long-term impact on regulatory function success, and guide teams through ambiguity and evolving data.
What you'll bring
- Minimum of 12–15+ years of regulatory affairs experience in biotechnology or pharmaceutical industry.
- Experience spanning early clinical development (Phase 1/2) through later-stage development global regulatory strategy for oncology or related therapeutic areas.
- Direct experience with IND and global CTA submissions, including EU CTR.
- Proven track record of leading health authority interactions (FDA and ex-US) and influencing development strategy.
- Ability to operate effectively in environments with uncertainty, shifting priorities, and incomplete data.
- Demonstrated ability to work with complex and abstract problems across multiple functional areas.
- Strong leadership skills, including experience mentoring, developing, and influencing teams.
- Ability to lead through influence across functions without direct authority.
- Experience managing regulatory risk and translating requirements into practical development strategies.
- Excellent communication skills, with the ability to clearly articulate regulatory strategy to both technical and non-technical stakeholders.
- Strong executive presence with the ability to influence and negotiate at senior levels internally and externally.
- Strong project management and organizational skills in a fast-paced environment.