Regulatory Submissions Lead — Dossier Planning & Ops

Exelixis; Alameda (CA); On-site; USD 158,000 - 223,000; Full time

Benefits offered by this job

401k

Medical insurance

Dental insurance

Vision insurance

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus

Stock purchase plan

Long-term incentives

Vacation days

Paid holidays

Sick days

Job summary

Exelixis seeks an Associate Regulatory Operations Director to oversee submission activity for our global portfolio, ensuring staffing and timely filings. The role requires deep knowledge of regulatory submission requirements and collaboration across Regulatory Affairs and cross-functional teams to achieve filing objectives.

The candidate will guide Veeva RIM practices, develop best practices for submission timelines, mentor staff, interpret guidelines, and drive process improvements to enhance

Qualifications

• Bachelor's degree in related discipline with 11+ years of experience or
• Master's degree with 9+ years of experience; PhD with 5+ years
• Equivalent combination of education and experience.

Responsibilities

• Oversee planning of all regulatory submissions (INDs, NDAs, BLAs) in electronic format.
• Oversee regulatory submission processes, timelines, and deliverables.
• Collaborate with Regulatory Affairs and cross-functional teams to maintain global submission project plans.
• Lead cross-functional team to explore submission process optimization.
• Develop submission planning best practices and major timeline implementations.
• Mentor Regulatory Operations staff on submission planning best practices.
• Review and interpret regulatory guidelines.

Skills

Regulatory submissions planning

Cross-functional collaboration

Strategic planning

Communication

Leadership

Project management

Veeva RIM

Education

Bachelor's degree in related discipline

Master's degree in related discipline

PhD in related discipline

Equivalent combination of education and experience

Tools

Veeva RIM

Project planning tools

Job description

Exelixis seeks an Associate Regulatory Operations Director to oversee submission activity for our global portfolio, ensuring staffing and timely filings. The role requires deep knowledge of regulatory submission requirements and collaboration across Regulatory Affairs and cross-functional teams to achieve filing objectives.

The candidate will guide Veeva RIM practices, develop best practices for submission timelines, mentor staff, interpret guidelines, and drive process improvements to enhance