Associate Director, Regulatory Project Management (remote)

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is hiring an Associate Director, Regulatory Project Management to lead regulatory project management across Global Regulatory Affairs. The role coordinates development program timelines, submission planning and delivery, cross-functional work, documentation, risk management, and stakeholder updates.

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