Associate Regulatory Affairs Strategy Director (Oncology)

Join Exelixis in Alameda, Alameda County as an Associate Regulatory Affairs Strategy Director, where you'll develop and execute global regulatory strategies that advance our oncology therapies while meeting evolving health authority requirements.

About the Role

This full-time position offers strategic leadership in regulatory affairs, working closely with cross-functional teams to navigate complex global health authority landscapes. You'll ensure our regulatory submissions are scientifically sound, strategically aligned with asset and corporate objectives, and positioned for success in international markets.

What You'll Do

• Develop and implement global regulatory strategies that support oncology asset progression from development through commercialization
• Lead preparation and submission of regulatory documentation to health authorities worldwide, maintaining scientific rigor and organizational consistency
• Translate regulatory requirements into clear, actionable timelines and implementation plans for internal stakeholders
• Partner with clinical, medical, and commercial teams to align regulatory strategy with asset and corporate goals
• Maintain current expertise in regulatory pathways and communicate regulatory landscape developments to key partners
• Manage regulatory milestones and submission schedules to support program advancement

What We're Looking For

• Deep expertise in regulatory affairs strategy within oncology drug development
• Proven track record leading global regulatory submissions and health authority engagement
• Strong knowledge of FDA, EMA, and international regulatory pathways for therapeutic drugs
• Excellent ability to translate complex regulatory concepts for diverse audiences
• Demonstrated leadership experience collaborating across functional teams
• Advanced degree in a scientific discipline or equivalent professional regulatory affairs experience

About Exelixis

Exelixis is a biopharmaceutical company committed to developing and commercializing novel therapies that address critical unmet medical needs in oncology and other therapeutic areas.

How to Apply

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.