Associate Director, Regulatory Project Management

Eli Lilly and Company

. Develop and maintain integrated project plans for regulatory submissions, including IND, NDA, BLA, and MAA, and post-approval activities .

Posted 10/8/2026full-timeRemote • United StatesSenior💰 $136,500 - $220,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory project management, including the development and maintenance of integrated project plans for submissions such as IND, NDA, BLA, and MAA. Proficient in coordinating cross-functional collaboration and ensuring compliance with regulatory frameworks and documentation standards.

Highest-signal resume keywords

Regulatory Submissions ManagementProject Management Tools ProficiencyRegulatory Frameworks UnderstandingCross-Functional CollaborationRisk Assessment and Mitigation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsProject ManagementRegulatory DocumentationBudget TrackingRegulatory Compliance

Soft Skills

Interpersonal SkillsCommunication SkillsAnalytical AbilitiesProblem-Solving SkillsAttention to Detail

Tools & Technologies

Microsoft ProjectSmartsheet

Certifications & Qualifications

PMPPRINCE2RAC

Industry Keywords

INDNDABLAMAAGlobal Health Authorities

Tech Stack

Tools & technologies

AssemblyPMP

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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