Associate Regulatory Affairs Director – Quality, Standards & Training

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee compliance for the Global Patient Safety and Regulatory Affairs divisions, with a primary focus on Regulatory Affairs.

• Evaluate, report, and communicate performance metrics against compliance indicators and inspection-readiness standards.

• Lead initiatives for compliance monitoring and identify potential compliance and operational risks.

• Promote process standardization, consistency, and initiatives for continuous improvement.

• Supervise updates to the SmPC for commercially sourced products in Exelixis-sponsored studies.

• Keep precise Reference Safety Information trackers, including submission dates and approvals from health authorities.

• Monitor the timely receipt of partner IBs and health authority submissions across various programs.

• Ensure completion of RFIs within specified SOP timelines.

• Oversee compliance of aggregate reports submitted to health authorities and CROs.

• Verify that Regulatory Affairs documents in the Trial Master File and Veeva RIM are up-to-date and comprehensive.

• Track training compliance for Regulatory Affairs through the LMS.

• Ensure timely and accurate updates of Regulatory Affairs SOPs.

• Maintain up-to-date contact information for Regulatory Affairs in relation to each study with health authorities.

• Assist the Regulatory Affairs Strategy Team in development programs.

• Analyze compliance metrics and contribute to dashboards and presentations for leadership.

• Aid in the investigation, tracking, and resolution of Quality Events, including conducting root cause analysis and CAPAs.

• Collaborate with subject matter experts on deviation assessments and documentation.

• Coordinate impact assessments for new regulations and support the implementation of related plans.

• Assist with health authority inspections and ensure ongoing inspection readiness.

• Draft, review, and maintain procedures and standards for Regulatory Affairs.

• Keep training matrices current and align training requirements with both procedural and regulatory expectations.

• Identify and provide quality-related training for members of the Regulatory Affairs team.

• Execute additional duties as assigned.

• Adhere to all company policies and standards.

⛳️ Requirements

• Bachelor's degree in a related field and at least 11 years of relevant experience; or a Master's degree in a related field with a minimum of 9 years of relevant experience; or a comparable combination of education and experience.

• 7–10 years of experience in regulatory affairs within the pharmaceutical industry.

• Experience with audits and inspections is preferred but not mandatory.

• Profound understanding of the regulatory framework, industry drivers, and best practices.

• Capability to create and manage plans, set timelines, and establish performance standards.

• Excellent verbal and written communication abilities.

• Strong interpersonal skills with the capacity to accommodate different viewpoints to influence resolutions.

• Competence in gathering, analyzing, and applying essential information to resolve issues.

• Proactive in assessing workload, trends, tasks, and priorities.

• Ability to plan and manage multiple activities simultaneously.

• Capacity to consider alternative methods and develop contingency plans.

• Willingness to travel up to 10% as required.

🏝️ Benefits

• 401k plan with generous contributions from the company.

• Group medical, dental, and vision insurance coverage.

• Life and disability insurance options.

• Flexible spending accounts available.

• Participation in a discretionary annual bonus program.

• Opportunity to purchase stock in the company.

• Long-term incentive programs.

• 15 days of accrued vacation in the first year.

• 17 paid holidays, including a company-wide winter shutdown in December.

• Up to 10 sick days offered throughout the calendar year.

• Provision of necessary equipment, including dual monitors and ergonomic chairs.

• Disability accommodations provided during the recruitment process.