Associate Director, Regulatory Project Management

🕒 October 8

🇺🇸 United States – Remote

💵 $136.5k - $220k / year

⏰ Full Time

🟠 Senior

👷‍♀️ Project Manager

👻 Ghost score 10%

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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 multinational pharmaceutical company that researches, develops, manufactures, and markets prescription medicines across multiple therapeutic areas including diabetes, oncology, immunology, neuroscience, and pain. Headquartered in Indianapolis, Indiana, Lilly is known for its extensive R&D, clinical development, and global commercialization of biologic and small-molecule drugs. The company focuses on drug discovery, clinical trials, regulatory approvals, and large-scale pharmaceutical manufacturing and distribution.

📋 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 • Create contingency plans to maintain compliance and meet milestones • 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 accuracy and consistency of regulatory documentation • 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 key 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 • Proficiency in project management methodologies such as PMP, PRINCE2, and RAC • Excellent interpersonal and communication skills • Analytical and problem-solving abilities • Keen attention to detail • Ability to manage multiple priorities while navigating evolving regulatory requirements and project constraints

🏖️ Benefits

• Company bonus depending in part on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical, dental, vision and prescription drug benefits • 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