Remote Regulatory Project Director

Eli Lilly and Company; United States; Remote; USD 137,000 - 220,000; Full time

Benefits offered by this job

Company bonus

401(k)

Pension

Vacation benefits

Medical, dental, vision benefits

Flexible benefits

Life insurance

Time off and leave benefits

Well-being benefits

Job summary

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, seeks an Associate Director, Regulatory Project Management to lead regulatory submissions from IND through NDA/BLA. This remote US-based role demands strong planning, cross-functional coordination, and meticulous risk management with executive visibility.

You will partner with Clinical, Nonclinical, CMC, Quality, and Commercial teams, ensure submission readiness, maintain documentation, manage budgets, and report

Qualifications

• RPMs require a blend of regulatory knowledge and project management expertise.
• 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
• Communication skills are crucial for interacting with regulatory bodies, internal management, and cross-functional teams, facilitating collaboration and maintaining project alignment
• 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

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

Stakeholder management

Communication skills

Regulatory knowledge

Analytical thinking

Education

Bachelor’s degree in a scientific or related field

Tools

Microsoft Project

Smartsheet

PMP

PRINCE2

RAC

Job description

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, seeks an Associate Director, Regulatory Project Management to lead regulatory submissions from IND through NDA/BLA. This remote US-based role demands strong planning, cross-functional coordination, and meticulous risk management with executive visibility.

You will partner with Clinical, Nonclinical, CMC, Quality, and Commercial teams, ensure submission readiness, maintain documentation, manage budgets, and report