SUMMARY/JOB PURPOSE
The Associate RA Quality, Standards & Training Director provides compliance oversight for the Global Patient Safety (GPS) and Regulatory Affairs function, with primary focus on Regulatory Affairs activities. The role applies strong regulatory strategy knowledge to monitor, assess, and communicate performance against key compliance indicators. metrics and inspection-readiness standards. The Associate Director drives process standardization and consistency by leading compliance monitoring activities, proactively identifying compliance and operational risks, and advancing continuous improvement initiatives. Working cross-functionally with Clinical Operations, Clinical Development and Quality Assurance, the role supports alignment to regulatory standards, mitigates compliance risk, and strengthens organizational inspection readiness.
ESSENTIAL DUTIES/RESPONSIBILITIES
- Accountable for monitoring SmPC updates for commercially sourced products in Exelixis-sponsored studies.
- Ensure accuracy of Reference Safety Information (RSI) trackers to include timely updates of health authority submission dates and approvals.
- Track receipt of partner IBs and ensure timely health authority submissions across programs.
- Track RFis to completion within the timelines as required per SOP.
- Monitor aggregate report compliance to health authorities and CROs.
- Work with Regulatory Affairs Strategist, CRO and Clinical Operations to ensure the Trial Master File (TMF) and Veeva RIM is kept current and complete for Regulatory Affairs related documents.
- Monitor Regulatory Affairs training compliance via LMS.
- Oversee the timely and accurate update of Regulatory Affairs SOPs by working with SOP owners.
- Accountable for Regulatory Affairs points of contact for each study kept current with the health authorities.
- Assist Regulatory Affairs Strategy Team on development programs as needed.
- Monitor and analyze key compliance metrics to assess adherence to applicable procedures, regulations and internal standards.
- Contribute to the development of leadership dashboards and slide decks, summarizing compliance performance and trends.
- Support the investigation, tracking and timely closure of Quality Events, including root cause analysis and development of corrective and preventative actions (CAPAs), as required.
- Collaborate closely with SMEs to support deviation assessment and authorship, ensuring timely and high quality documentation.
- Coordinate with GPS and Regulatory Affairs SMEs to conduct impact assessments for new and evolving regulations and support development of implementation plans.
- Collaborate with Quality Assurance and cross-functional stakeholders to support health authority inspections across GPS and Regulatory Affairs ensuring the RA function remains in a continuous state of inspection readiness.
- Author, review and maintain procedures and standards relevant to Regulatory Affairs.
- Partner with Corporate Training to maintain training matrices and ensure training requirements are current and aligned with procedural and regulatory expectations.
- Identify and conduct quality-related training to regulatory affairs team members.
- Performs other duties as assigned
- Complies with all policies and standards
SUPERVISORY RESPONSIBILITIES
EDUCATION/EXPERIENCE/KNOWLEDGE/SKILLS & ABILITIES
Education
- 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.
Experience
- 7 - 10 years of regulatory affairs experience in the pharmaceutical industry.
- Experience with audits and inspections preferred, but not required.
Knowledge, Skills and Abilities
Required:
- 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.
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Travel Requirements
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: ApplicantAccommodations@exelixis.com.
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.
DISCLAIMER:
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.