Associate Regulatory Affairs Director, Quality & Training

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

Benefits offered by this job

401k plan

Medical, dental and vision insurance

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus

Job summary

Exelixis, Inc. is seeking an Associate RA Quality, Standards & Training Director to provide compliance oversight for GPS and Regulatory Affairs, leveraging regulatory strategy to enhance inspection readiness and risk management across programs.

You will lead standardization, monitor metrics, maintain TMF & Veeva RIM, oversee training matrices, and collaborate with cross-functional teams to sustain a robust quality program.

Qualifications

• Ability to develop and manage plans, establish timelines and set standards for performance.
• Extensive knowledge of the regulatory framework to develop innovative approaches and manage complex work.
• Strong verbal and written communication; ability to present to cross-functional groups.
• Interpersonal skills to influence resolutions across teams.
• Regulatory expertise for cross-functional teams and strategic planning.
• Ability to balance workload and execute multiple activities.
• Consider alternative methods and contingency plans to avoid issues.

Responsibilities

• Monitor Regulatory Affairs compliance metrics and inspection readiness.
• Maintain TMF and Veeva RIM for RA documents.
• Track RSI trackers and health authority submission dates.
• Oversee SOP updates and maintain regulatory procedures.
• Coordinate RA training matrices with Corporate Training.
• Support development programs for Regulatory Strategy Team.
• Collaborate with Quality Assurance for inspections readiness.

Skills

Regulatory strategy

Regulatory affairs

Audit & inspections

Project planning

Cross-functional collaboration

Education

Bachelor's degree in related discipline

Master's degree in related discipline

Equivalent combination of education and experience

Job description

Exelixis, Inc. is seeking an Associate RA Quality, Standards & Training Director to provide compliance oversight for GPS and Regulatory Affairs, leveraging regulatory strategy to enhance inspection readiness and risk management across programs.

You will lead standardization, monitor metrics, maintain TMF & Veeva RIM, oversee training matrices, and collaborate with cross-functional teams to sustain a robust quality program.