Global Regulatory Strategy Executive Director

Exelixis, Inc.; Alameda (CA); Hybrid; USD 269,000 - 380,000; Full time

Benefits offered by this job

401k plan

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

Flexible spending accounts

Discretionary annual bonus

Stock options

Paid vacation and holidays

Sick days

Job summary

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

Lead global regulatory strategies across clinical, non-clinical, and CMC disciplines, translating requirements into practical plans and guiding timely, high-quality submissions. You will mentor the regulatory team, coordinate meetings with agencies, and maintain strong Health Authority interactions.

Qualifications

• BS/BA degree in related discipline with 18+ years of related experience, or MS/MA with 16+ years, or PhD with 15 years, or equivalent.
• May require certification in assigned area.
• Minimum 18 years pharmaceutical industry and/or regulatory agency experience.

Responsibilities

• Oversee Regulatory Program Leaders and their staff.
• Oversee development of plans incorporating regulatory strategies to maximize chances of successful registration.
• Maintain FDA relationships and understand regulatory climate.
• Ensure submission documents are complete, high-quality, compliant and well organized.

Skills

Regulatory strategy

Leadership

FDA experience

Cross-functional collaboration

Regulatory communication

Problem solving

Education

BS/BA in related discipline

MS/MA in related discipline

PhD in related discipline

Job description

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

Lead global regulatory strategies across clinical, non-clinical, and CMC disciplines, translating requirements into practical plans and guiding timely, high-quality submissions. You will mentor the regulatory team, coordinate meetings with agencies, and maintain strong Health Authority interactions.