Associate Director, Regulatory Project Management (remote)

Lilly • Indianapolis, IN

23h • $136,500 - $220,000 • Remote

About The Position

The Associate Director, Regulatory Project Management provides project management leadership across Global Regulatory Affairs, supporting assigned development programs and portfolio priorities. The role serves as the central hub for regulatory projects and is accountable for regulatory project timelines, including effective planning, tracking, execution, and delivery of submissions to health authorities worldwide.

The Regulatory Project Manager partners across the Regulatory function to coordinate deliverables, maintain oversight of submission plans, and ensure regulatory documents are complete, accurate, and submitted on schedule. The role maintains project records and documentation to support compliance, audit readiness, and regulatory transparency. It also provides regular updates to leadership and key stakeholders on project status, risks, challenges, and milestones to support alignment and informed decision-making.

The position requires strong organizational, communication, problem-solving, and time management skills, keen attention to detail, and the ability to manage multiple priorities while navigating evolving regulatory requirements and project constraints. It is a remote position based in the United States, with occasional travel.

Requirements

• Bachelor’s degree in a scientific or related field.
• At least 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 or Smartsheet, and methodologies such as PMP, PRINCE2, or RAC.
• Excellent interpersonal and communication skills for engaging stakeholders, facilitating meetings, and driving decision-making.
• Analytical and problem-solving abilities to interpret regulatory requirements and translate them into actionable project tasks.
• Attention to detail when preparing accurate documentation and maintaining regulatory compliance.
• Strong organizational and time management skills, including the ability to manage multiple priorities.

Responsibilities

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

Benefits

• Company bonus, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior