Remote Associate Director, Regulatory Project Management

Remote Queer; United States; Remote; USD 137,000 - 220,000; Full time

Benefits offered by this job

Bonus program

401(k) plan

Health benefits

Pension

Vacation benefits

Flexible spending accounts

Life insurance

Well-being program

Job summary

Lilly seeks an Associate Director, Regulatory Project Management to provide leadership across Global Regulatory Affairs. You will drive timelines for submissions and ensure regulatory documents are complete and on schedule, coordinating with Clinical, Nonclinical, CMC, Quality, and Commercial groups.

The role requires senior PM expertise, strong communication, and a diligent eye for detail to support IND, NDA, BLA, and other regulatory activities. This remote US-based position includes travel.

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.
• Proficiency with PM tools (Microsoft Project, Smartsheet) and methodologies (PMP, PRINCE2, RAC) for planning, tracking, and reporting.
• Excellent interpersonal and communication skills to engage stakeholders and drive decisions.

Responsibilities

• Develop and maintain integrated project plans for regulatory submissions (IND, NDA, BLA) and post-approval activities.
• Coordinate with cross-functional teams to ensure on-time submissions and regulatory readiness.
• Identify and mitigate regulatory risks; create contingency plans.
• Manage interactions with health authorities and prepare teams for agency meetings.
• Oversee authoring, review, and assembly of submission-ready dossiers.
• Forecast budgets and report financial performance to leadership.

Skills

Regulatory knowledge

Project management

Communication skills

Analytical thinking

Problem solving

Attention to detail

Education

Bachelor’s degree in a scientific or related field

Tools

Microsoft Project

Smartsheet

Job description

Lilly seeks an Associate Director, Regulatory Project Management to provide leadership across Global Regulatory Affairs. You will drive timelines for submissions and ensure regulatory documents are complete and on schedule, coordinating with Clinical, Nonclinical, CMC, Quality, and Commercial groups.

The role requires senior PM expertise, strong communication, and a diligent eye for detail to support IND, NDA, BLA, and other regulatory activities. This remote US-based position includes travel.