Associate Director, Regulatory Project Management
About The Position
Centessa Pharmaceuticals, a clinical-stage company developing orexin receptor 2 (OX2R) agonists, is seeking an Associate Director, Regulatory Project Management. This role provides project management leadership across Global Regulatory Affairs, supporting development programs and portfolio priorities. The Associate Director will serve as the central hub for regulatory projects, ensuring effective planning, tracking, execution, and delivery of submissions to health authorities worldwide. This position requires strong organizational, communication, problem-solving, and time management skills, with keen attention to detail and the ability to manage multiple priorities while navigating evolving regulatory requirements and project constraints.
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
Responsibilities
- 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 standards.
- Act as the primary regulatory contact for timelines from functions including Clinical, Nonclinical, CMC, Quality, and Commercial, fostering collaboration and alignment.
- Identify, assess, and mitigate project risks, creating contingency plans to maintain compliance and meet milestones.
- Coordinate with Regulatory Strategy Lead to manage interactions with global health authorities, prepare teams for agency meetings, and lead responses to regulatory queries.
- Coordinate the authoring, review, and assembly of submission-ready regulatory dossiers, ensuring accuracy and consistency.
- Develop and track project budgets, forecast expenditures, and report financial performance to leadership.
Benefits
- 401(k) plan
- company-sponsored medical, dental, vision, and life insurance
- generous paid time off
- health and wellness program
- discretionary annual bonus
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What This Job Offers
Job Type
Full-time
Career Level
Manager
