Regulatory Affairs Quality & Standards Director

Exelixis; United States; On-site; USD 163,000 - 231,000; Full time

Benefits offered by this job

401k plan

Medical/dental/vision

Life insurance

Disability insurance

Flexible spending accounts

Annual bonus

Stock purchase program

Vacation & holidays

Sick days

Job summary

Exelixis is seeking an Associate RA Quality, Standards & Training Director to provide compliance oversight for GPS and Regulatory Affairs, with emphasis on regulatory strategy, performance monitoring, and inspection readiness. This role leads cross-functional standardization to mitigate compliance risks across studies.

Ideal candidates will have 7–10 years in regulatory affairs, strong communication skills, and a proven ability to drive continuous improvement within a fast-paced biopharma

Qualifications

• Bachelor's degree in related discipline with a minimum of 11 years of related experience; or, Master's degree with a minimum of 9 years of related experience; or, equivalent combination of education and experience.
• 7 - 10 years of regulatory affairs experience in the pharmaceutical industry.
• Experience with audits and inspections preferred, but not required.

Responsibilities

• Monitor SmPC updates for commercially sourced products in Exelixis-sponsored studies.
• Ensure accuracy of RSI trackers including timely health authority submission dates and approvals.
• Track RFis to completion within SOP timelines.
• Monitor aggregate report compliance to health authorities and CROs.
• Oversee TMF and Veeva RIM for Regulatory Affairs documents.

Skills

Regulatory strategy

Regulatory affairs

Cross-functional collaboration

Regulatory compliance

Problem solving

Education

Bachelor's degree in life sciences

Master's degree in related discipline

Tools

Veeva RIM

Audit & inspections

Job description

Exelixis is seeking an Associate RA Quality, Standards & Training Director to provide compliance oversight for GPS and Regulatory Affairs, with emphasis on regulatory strategy, performance monitoring, and inspection readiness. This role leads cross-functional standardization to mitigate compliance risks across studies.

Ideal candidates will have 7–10 years in regulatory affairs, strong communication skills, and a proven ability to drive continuous improvement within a fast-paced biopharma