Note: The job is a remote job and is open to candidates in USA. Centessa Pharmaceuticals is a clinical-stage company developing orexin receptor 2 agonists for narcolepsy and other sleep-wake disorders. The Associate Director, Regulatory Project Management provides project management leadership across Global Regulatory Affairs, coordinating regulatory submissions, timelines, risks, documentation, budgets, and cross-functional deliverables. The role also supports health authority interactions and communicates project status and milestones to leadership and stakeholders.
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
- * 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
- The Associate Director, Regulatory Project Management role is based in the US, with occasional travel
Benefits
- Discretionary annual bonus
- 401(k) plan
- Company-sponsored medical insurance
- Company-sponsored dental insurance
- Company-sponsored vision insurance
- Company-sponsored life insurance
- Generous paid time off
- Health and wellness program
Company Overview
Company H1B Sponsorship