Global Regulatory Strategy Director

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

Benefits offered by this job

401k plan

Medical coverage

Dental coverage

Vision coverage

Life & disability insurance

Flexible spending accounts

Discretionary annual bonus

Stock purchase plan

Long-term incentives

Vacation 15 days

Holidays 17

Job summary

Exelixis, a leader in oncology, seeks an Executive Director, Regulatory Affairs to guide global regulatory strategies from early development through post-approval. You will oversee program leaders, ensure timely IND/NDAs/BLAs submissions, and maintain strong FDA relationships to accelerate approvals.

The role requires extensive regulatory leadership experience, expertise in oncology programs, and the ability to translate complex regulations into actionable plans while guiding cross-functional

Qualifications

• Minimum 18 years of pharmaceutical industry or regulatory agency experience.
• Minimum nine years of regulatory leadership experience.
• Experience with FDA review divisions and oncology drug development.
• Proven ability to lead teams and manage programs.

Responsibilities

• Oversight of Regulatory Program Leaders and staff.
• Develop and implement global regulatory strategies to maximize approvals.
• Understand FDA policies and maintain a good FDA relationship.
• Ensure high-quality, compliant regulatory submissions.
• Coordinate meetings with regulatory agencies.
• Advise management on regulatory, legal and scientific issues.
• Lead cross-functional collaboration across clinical, non-clinical and CMC.

Skills

Regulatory leadership

FDA experience

Regulatory strategy

Submission management

Cross-functional leadership

Regulatory affairs

Education

BS/BA in related field

MS/MA in related field

PhD in related field

Equivalent experience

Job description

Exelixis, a leader in oncology, seeks an Executive Director, Regulatory Affairs to guide global regulatory strategies from early development through post-approval. You will oversee program leaders, ensure timely IND/NDAs/BLAs submissions, and maintain strong FDA relationships to accelerate approvals.

The role requires extensive regulatory leadership experience, expertise in oncology programs, and the ability to translate complex regulations into actionable plans while guiding cross-functional