Associate Regulatory Affairs Quality, Standards & Training Director (Global Pati

• Bachelor's degree in related discipline and a minimum of 11 years of related experience; or,
• Master's degree in related discipline and 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.

• 10% Travel required.

Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $163,000 - $231,000 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

If you have a disability and need an accommodation in relation to the recruiting process, please email us at: .

WORKING CONDITIONS:

Our office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.

• Ability to develop and manage plans, establish timelines and set standards for performance. Proactively balances commitment and overcomes challenges to complete multiple activities and achieve results. Takes pride in delivering high-quality work.
• Applies extensive knowledge of the regulatory framework, industry drivers and practices to develop innovative approaches and manage complex work.
• Demonstrates clear and effective verbal and written communication. Provides timely and appropriate information updates. Speaks clearly and confidently in one-on-one situations and effectively presents information to cross-functional groups of colleagues.
• Strong interpersonal skills and ability to accommodate differing views to influence an agreed upon resolution.
• Applies knowledge of organizational goals and objectives and demonstrates advanced skill and insight in gathering, analyzing and applying key information to solve problems. Provides regulatory expertise to cross-functional teams. Understands longer term consequences of decisions and actions.
• Capable of proactively assessing workload, trends, tasks and priorities for area of responsibility.
• Ability to plan and execute multiple activities.
• Ability to consider alternative methods and contingency plans to avoid potential issues.