Remote Regulatory Project Director

BioSpace; Indianapolis (IN); Remote; USD 137,000 - 220,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Vacation benefits

Medical benefits

Dental benefits

Vision benefits

Flexible benefits

Life insurance

Well-being benefits

Job summary

Lilly is seeking an Associate Director, Regulatory Project Management for a remote US‑based role with occasional travel. You will lead regulatory submission planning, cross‑functional coordination, and risk management to ensure on‑time IND/NDA submissions and post‑approval activities.

The role emphasizes strong communication with global health authorities, budget oversight, and collaboration with Clinical, Nonclinical, CMC, Quality, and Commercial teams to deliver compliant strategies that

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.

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 standard
• 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

Skills

Regulatory project management

Cross-functional coordination

Risk management

Communication with regulatory bodies

Budget and resource management

Education

Bachelor's degree in a scientific or related field

Tools

Microsoft Project

Smartsheet

Job description

Lilly is seeking an Associate Director, Regulatory Project Management for a remote US‑based role with occasional travel. You will lead regulatory submission planning, cross‑functional coordination, and risk management to ensure on‑time IND/NDA submissions and post‑approval activities.

The role emphasizes strong communication with global health authorities, budget oversight, and collaboration with Clinical, Nonclinical, CMC, Quality, and Commercial teams to deliver compliant strategies that