Associate Director, Regulatory Project Management

🔥 14 hours ago

🇺🇸 United States – Remote

💵 $136.5k - $220k / year

⏰ Full Time

🟠 Senior

👷‍♀️ Project Manager

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Eli Lilly and Company

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

💰 $6.5M Post-IPO Debt - Eli Lilly on 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company is a global pharmaceutical company that researches, develops, manufactures, and distributes prescription medicines and provides patient support services. The company focuses on life-changing medicines across conditions such as diabetes, cancer, Alzheimer’s disease, autoimmune disorders, dermatology, migraine, obesity, and sleep apnea; it runs clinical trials, offers LillyDirect pharmacy services, and emphasizes manufacturing quality, medication safety, and research into genetic medicines. Eli Lilly also provides patient resources, condition education, and access programs to help people find care and participate in trials.

📋 Description

• Develop and maintain integrated project plans for regulatory submissions, including IND, NDA, BLA, and MAA, and post-approval activities • Ensure adherence to project scope, timelines, budgets, and quality standards • Act as the primary regulatory contact for timelines from Clinical, Nonclinical, CMC, Quality, and Commercial functions • Foster cross-functional collaboration and alignment • Identify, assess, and mitigate project risks and create contingency plans • Coordinate interactions with global health authorities • Prepare teams for agency meetings and lead responses to regulatory queries • Coordinate authoring, review, and assembly of submission-ready regulatory dossiers • Ensure regulatory documentation accuracy and consistency • Develop and track project budgets, forecast expenditures, and report financial performance to leadership • Maintain project records and documentation for compliance, audit readiness, and regulatory transparency • Provide leadership and stakeholders with updates on project status, risks, challenges, and milestones

🎯 Requirements

• Bachelor’s degree in a scientific or related field • 8+ years of industry-based regulatory experience • Strong understanding of regulatory frameworks and compliance requirements in relevant industries • Proficiency in project management tools such as Microsoft Project and Smartsheet • Knowledge of project management methodologies such as PMP, PRINCE2, and RAC • Excellent interpersonal and communication skills • Analytical and problem-solving abilities to interpret regulatory requirements and translate them into actionable project tasks • Strong attention to detail for preparing accurate documentation and maintaining regulatory compliance

🏖️ Benefits

• Company bonus depending partly on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical, dental, vision, and prescription drug benefits • Flexible benefits, including healthcare and/or dependent day care flexible spending accounts • Life insurance and death benefits • Time off and leave of absence benefits • Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities • Occasional travel

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