Associate Director, Regulatory Project Management

Lilly, through its wholly owned subsidiary Centessa Pharmaceuticals, develops medicines for narcolepsy and other sleep-wake disorders. The Associate Director, Regulatory Project Management provides leadership across Global Regulatory Affairs by planning, coordinating, tracking, and delivering regulatory submissions and post-approval activities. The role manages cross-functional collaboration, risks, documentation, budgets, and communications with leadership and health authorities.

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

Requirements:

• 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