Senior Regulatory Operations Manager

Job not on LinkedIn

🔥 24 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $165k - $208.5k / year

⏰ Full Time

🟠 Senior

⚙️ Operations

🦅 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

• Manage and independently execute regulatory submission planning, publishing, quality control, delivery, archiving and lifecycle management • Provide eCTD technical expertise and manage submission plans in Veeva RIM • Format, publish, transmit and archive Health Authority submissions • Serve as subject matter expert for regulatory publishing and document management technologies • Provide guidance on eCTD structure, content readiness, publishing, validation, dispatch and lifecycle management • Perform document- and submission-level technical quality control • Identify IT solutions, automation opportunities and technology enhancements for Regulatory Operations • Create regulatory submission objectives, content plans and documentation within Veeva RIM • Review evolving FDA electronic submission requirements and technical standards and implement changes • Collaborate on SOPs, work instructions, templates, checklists, standards and best practices • Perform other duties as assigned • Comply with all policies and standards

🎯 Requirements

• Bachelor’s degree in related discipline and a minimum of nine years of related experience; or Master’s degree and a minimum of seven years; or PhD and a minimum of two years; or equivalent combination of education and experience • Subject matter expertise in regulatory publishing and document management technologies, including LORENZ docubridge, Veeva Vault RIM, Microsoft Word, Adobe Acrobat and regulatory validation tools • Knowledge of regulatory framework and industry practices • Ability to manage time and resources and complete tasks within established timelines • Clear and effective verbal and written communication • Good interpersonal and collaborative skills • Ability to gather, analyze and apply information to solve problems • Ability to manage and execute own work with integrity • Approximately 20% travel

🏖️ 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 • Reasonable accommodations for qualified individuals with disabilities

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