Associate Director, Regulatory Project Management

Lilly • Indianapolis, IN

10d • $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. As the central hub for regulatory projects, the role is accountable for regulatory project timelines and effective planning, tracking, execution, and delivery of submissions to health authorities worldwide.

The role partners across Regulatory and with Clinical, Nonclinical, CMC, Quality, Commercial, and other functions to coordinate deliverables, maintain oversight of submission plans, and ensure regulatory documents are complete, accurate, and submitted on schedule. It maintains project records and documentation to support compliance, audit readiness, and regulatory transparency, and provides leadership and stakeholders with updates on project status, risks, challenges, and milestones.

This is a remote position based in the United States, with occasional travel. The anticipated wage is $136,500–$220,000. Full-time equivalent employees are eligible for a company bonus, depending in part on company and individual performance. Eligible employees may also participate in a comprehensive benefits program.

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 project management methodologies such as PMP, PRINCE2, or RAC.
• Excellent interpersonal and communication skills to engage stakeholders, facilitate meetings, and drive decision-making.
• Analytical and problem-solving abilities to interpret regulatory requirements and translate them into actionable project tasks.
• Strong organizational, communication, problem-solving, and time-management skills, attention to detail, and ability to manage multiple priorities amid evolving regulatory requirements and project constraints.

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.
• Serve as the primary regulatory contact for timelines across Clinical, Nonclinical, CMC, Quality, and Commercial 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 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 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.
• 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: Director