Associate Director, Regulatory Project Management

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $136.5k - $220k / year

⏰ Full Time

🟠 Senior

👷‍♀️ Project Manager

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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 across 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 • Ability to manage multiple priorities and evolving regulatory requirements

🏖️ 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