Global Regulatory Strategy Leader

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

Job summary

Exelixis is seeking an Executive Director of Regulatory Affairs to lead global regulatory strategies across clinical, non-clinical and CMC disciplines from early development through post-approval.

The role requires extensive FDA interaction, high-level leadership of regulatory teams, and oversight of IND/NDAs/BLAs submissions to expedite approvals while ensuring compliance and high-quality documentation.

Qualifications

• BS/BA in a related discipline with extensive regulatory leadership experience.
• MS/MA in a related field with substantial regulatory background.
• PhD in a related field with many years in regulatory affairs.
• Equivalent combination of education and experience.
• Experience with FDA review divisions and oncology drug development is preferred.

Responsibilities

• Oversee Regulatory Program Leaders and staff.
• Develop plans incorporating regulatory strategies to maximize registration chances.
• Maintain FDA relationships and ensure high-quality submissions.
• Prepare INDs, NDAs, BLAs and related reports to regulatory agencies.
• Coordinate meetings with regulatory agencies and advisory committees.
• Mentor staff and develop individual development plans.
• Ensure timely completion of adverse event reports and safety submissions.

Skills

Executive leadership

Regulatory strategy

US FDA knowledge

Cross-functional leadership

Project management

eCTD knowledge

Education

BS/BA degree in related discipline

MS/MA degree in related discipline

PhD in related discipline

Equivalent combination of education and experience

Tools

Regulatory submissions software

eCTD preparation tools

Job description

Exelixis is seeking an Executive Director of Regulatory Affairs to lead global regulatory strategies across clinical, non-clinical and CMC disciplines from early development through post-approval.

The role requires extensive FDA interaction, high-level leadership of regulatory teams, and oversight of IND/NDAs/BLAs submissions to expedite approvals while ensuring compliance and high-quality documentation.