CMC Regulatory Dossier Management Director
ExelixisCalifornia, United States
Posted November 26, 2025
191500 - 272000 USD year
Full Time
About the Company
Every Exelixis employee is united in an ambitious cause: to transform science into new treatments that give cancer patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. As a diverse, growing team, everyone at Exelixis plays a role in advancing our mission through our innovative drug discovery, development and commercialization efforts. We take pride in our shared purpose, knowing the magnitude of our impact expands with every medicine we create and every form of cancer tumor type we treat. After operating in the challenging biotech sector for nearly three decades, we've evolved into a multi-platform cancer company with a proven track record of resiliency in the face of adversity. The success of our flagship commercial product set us up on our journey to discover and develop next-generation cancer treatments, driven by our relentless pursuit of results for the patients we serve. Cancer is our cause. Make it yours, too. Please see our Community Guidelines: bit.ly/4iBzJU0 For more information about Exelixis, please visit www.exelixis.com, follow @ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.
Job Description
This role provides PSC Regulatory expertise and leadership for biologics and Bioconjugates commercial and development projects, including leading development of high-quality regulatory submissions and managing submissions to regulatory authorities.
Requirements
- Bachelor's degree in related discipline and a minimum of thirteen years of related experience
- Minimum sixteen years pharmaceutical industry and/or regulatory agency experience or the equivalent combination of experience and education/training
- Prior experience working with Health Authorities and/or review divisions at FDA required
Benefits
- 401k plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program
- Sales-based incentive plan
- Opportunity to purchase company stock
- Long-term incentives
- 15 accrued vacation days in their first year
- 17 paid holidays including a company-wide winter shutdown in December
- Up to 10 sick days throughout the calendar year