Global Regulatory Affairs Executive Director

Regulatory Jobs; Alameda (CA); On-site; USD 269,000 - 380,000; Full time

Benefits offered by this job

401k plan

Medical, dental, vision coverage

Discretionary bonus program

Stock purchase plan

Paid holidays and vacation days

Job summary

Exelixis is seeking an Executive Director, Regulatory Affairs to oversee all regulatory activities from pre-IND to post-approval. You will lead a global team, develop strategies, ensure high-quality submissions, and interact with health authorities to secure timely approvals.

The role demands extensive FDA experience, leadership in oncology drug development, and a proven ability to translate complex regulations into practical plans and actions. Competitive compensation and benefits are provided.

Qualifications

• Minimum 18 years in pharma and/or regulatory agency work, incl. leadership roles.
• Experience with FDA review divisions and oncology drug development is required.
• Phased regulatory strategy development across pre-IND to post-approval.
• Ability to translate complex regulations into practical plans and actions.

Responsibilities

• Oversee Regulatory Program Leaders and staff to maximize registration chances.
• Manage preparation of INDs, NDAs, BLAs and regulatory submissions.
• Liaise with FDA and health authorities to expedite reviews and approvals.
• Provide regulatory guidance aligning study plans with company objectives.
• Develop and implement global regulatory strategies for new and existing programs.

Skills

Regulatory leadership

FDA experience

Oncology drug development

Strategic planning

Team leadership

Education

BS/BA in related field

MS/MA in related field

PhD in related field

Equivalent education/experience

Job description

Exelixis is seeking an Executive Director, Regulatory Affairs to oversee all regulatory activities from pre-IND to post-approval. You will lead a global team, develop strategies, ensure high-quality submissions, and interact with health authorities to secure timely approvals.

The role demands extensive FDA experience, leadership in oncology drug development, and a proven ability to translate complex regulations into practical plans and actions. Competitive compensation and benefits are provided.