[Hiring] Associate Director, Regulatory Project Management @Lilly

Role Description

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

• Partners across the Regulatory function to coordinate deliverables.
• Maintains oversight of submission plans.
• Ensures regulatory documents are complete, accurate, and submitted on schedule.
• Responsible for maintaining project records and documentation to support compliance, audit readiness, and regulatory transparency.
• Provides regular updates to leadership and key stakeholders, communicating project status, risks, challenges, and milestones.

Success in this role requires strong organizational, communication, problem-solving, and time management skills, with keen attention to detail and the ability to manage multiple priorities while navigating evolving regulatory requirements and project constraints.

Responsibilities

• Project Planning and Execution: Develop and maintain integrated project plans for regulatory submissions (e.g., IND, NDA, BLA, MAA) and post-approval activities, ensuring adherence to scope, timelines, budgets, and quality standards.
• Cross-Functional Coordination: Act as the primary regulatory contact for timelines from functions including Clinical, Nonclinical, CMC, Quality, and Commercial, fostering collaboration and alignment.
• Risk Management: Identify, assess, and mitigate project risks, creating contingency plans to maintain compliance and meet milestones.
• Regulatory Communication: Coordinate with Regulatory Strategy Lead to manage interactions with global health authorities, prepare teams for agency meetings, and lead responses to regulatory queries.
• Documentation Oversight: Coordinate the authoring, review, and assembly of submission-ready regulatory dossiers, ensuring accuracy and consistency.
• Budget and Resource Management: Develop and track project budgets, forecast expenditures, and report financial performance to leadership.

Qualifications

• 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 (e.g., Microsoft Project, Smartsheet) and methodologies (PMP, PRINCE2, RAC) for planning, tracking, and reporting.
• 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.
• Attention to detail is important for preparing accurate documentation and maintaining regulatory compliance.

Work Location

The Associate Director, Regulatory Project Management role is a remote position based in the US, with occasional travel.

Benefits

• Eligibility to participate in a company-sponsored 401(k); pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits (e.g., 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 (e.g., employee assistance program, fitness benefits, and employee clubs and activities).