Executive Director Global Regulatory Strategy & Submissions

Exelixis Inc; United States; On-site; USD 269,000 - 380,000; Full time

Benefits offered by this job

401k plan with company contributions

Comprehensive benefits package

Job summary

Exelixis Inc. is seeking an Executive Director, Regulatory Affairs to oversee all regulatory activities from pre-IND through BLA/NDA and post-approval.

You will develop global regulatory strategies across clinical, non-clinical, and CMC disciplines and translate requirements into practical plans. You will lead a team of Regulatory Program Leaders, manage interactions with regulatory agencies, and ensure timely, high-quality submissions in line with Exelixis best practices and timelines.

Qualifications

• Minimum 18 years pharmaceutical industry and/or regulatory agency experience.
• Minimum nine years regulatory experience in a position of substantial responsibility.
• Prior experience working with the relevant review divisions at FDA.
• Experience in oncology drug development required.

Responsibilities

• Oversee regulatory program leaders and staff to drive submissions.
• Develop plans incorporating regulatory strategies to maximize registrations.
• Maintain FDA relationships and ensure compliant submissions.
• Coordinate adverse event reports and regulatory timelines.

Skills

Regulatory leadership

FDA experience

Regulatory strategy

Analytical skills

Communication skills

Strategic thinking

Education

BS/BA in related discipline

MS/MA in related discipline

PhD in related discipline

Job description

Exelixis Inc. is seeking an Executive Director, Regulatory Affairs to oversee all regulatory activities from pre-IND through BLA/NDA and post-approval.

You will develop global regulatory strategies across clinical, non-clinical, and CMC disciplines and translate requirements into practical plans. You will lead a team of Regulatory Program Leaders, manage interactions with regulatory agencies, and ensure timely, high-quality submissions in line with Exelixis best practices and timelines.