Associate Regulatory Affairs Director – Quality, Standards & Training

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $163k - $231k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Exelixis

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1994

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $65M Post-IPO Equity on 2012-02

Healthcare • Biotechnology • Pharmaceuticals

Exelixis is a biotechnology and pharmaceutical company focused on developing cancer treatments through innovative research and development. The company is committed to advancing oncology by creating impactful cancer medicines, including biotherapeutics and small molecule therapies. Exelixis places a strong emphasis on clinical trials, collaborations, and a diverse range of treatment modalities, aiming to provide hope to cancer patients. Additionally, Exelixis is dedicated to sustainability, diversity, and community support, as reflected in their corporate values and practices.

📋 Description

• Provide compliance oversight for the Global Patient Safety and Regulatory Affairs functions, primarily Regulatory Affairs • Monitor, assess and communicate performance against compliance indicators, metrics and inspection-readiness standards • Lead compliance monitoring activities and identify compliance and operational risks • Advance process standardization, consistency and continuous improvement initiatives • Monitor SmPC updates for commercially sourced products in Exelixis-sponsored studies • Maintain accurate Reference Safety Information trackers, including health authority submission dates and approvals • Track partner IB receipt and timely health authority submissions across programs • Track RFIs to completion within SOP timelines • Monitor aggregate report compliance to health authorities and CROs • Ensure Regulatory Affairs documents in the Trial Master File and Veeva RIM remain current and complete • Monitor Regulatory Affairs training compliance via LMS • Oversee timely and accurate Regulatory Affairs SOP updates • Maintain current Regulatory Affairs points of contact for each study with health authorities • Support the Regulatory Affairs Strategy Team on development programs • Analyze compliance metrics and contribute to leadership dashboards and slide decks • Support investigation, tracking and closure of Quality Events, including root cause analysis and CAPAs • Collaborate with SMEs on deviation assessment and documentation • Coordinate impact assessments for new and evolving regulations and support implementation plans • Support health authority inspections and continuous inspection readiness • Author, review and maintain Regulatory Affairs procedures and standards • Maintain training matrices and align training requirements with procedural and regulatory expectations • Identify and conduct quality-related training for Regulatory Affairs team members • Perform other duties as assigned • Comply with all policies and standards

🎯 Requirements

• 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 • Extensive knowledge of the regulatory framework, industry drivers and practices • Ability to develop and manage plans, establish timelines and set standards for performance • Strong verbal and written communication skills • Strong interpersonal skills and ability to accommodate differing views to influence resolution • Ability to gather, analyze and apply key information to solve problems • Ability to proactively assess workload, trends, tasks and priorities • Ability to plan and execute multiple activities • Ability to consider alternative methods and contingency plans • 10% travel required

🏖️ Benefits

• 401k plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • Discretionary annual bonus program • Opportunity to purchase company stock • Long-term incentives • 15 accrued vacation days in the first year • 17 paid holidays including a company-wide winter shutdown in December • Up to 10 sick days throughout the calendar year • Necessary equipment, including dual monitors and ergonomic chairs • Disability accommodation during the recruiting process