Regulatory PM Director — Submissions & Strategy

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company; Boston (MA); On-site; USD 140,000 - 200,000; Full time

Benefits offered by this job

401(k) plan

Medical insurance

Dental insurance

Vision insurance

Life insurance

Generous paid time off

Wellness program

Job summary

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, seeks an Associate Director of Regulatory Project Management to lead global regulatory submissions and drive cross-functional coordination across Clinical, Nonclinical, CMC, Quality, and Commercial teams.

This role emphasizes planning, risk management, and timely regulatory communication with health authorities, ensuring accuracy and audit readiness.

Qualifications

• Bachelor’s degree in a scientific or related field.
• 8+ years of industry based regulatory experience.
• Strong understanding of regulatory frameworks and compliance requirements.
• Proficiency in PM tools (e.g., Microsoft Project, Smartsheet) and methodologies (PMP, PRINCE2, RAC).
• Excellent interpersonal and communication skills to engage stakeholders and drive decisions.
• Attention to detail for accurate regulatory documentation.

Responsibilities

• Develop and maintain integrated regulatory submission plans (IND, NDA, BLA, MAA) and post-approval activities.
• Coordinate with cross-functional teams to align timelines and deliverables.
• Identify risks and create contingency plans to maintain compliance and milestones.
• Lead regulatory interactions with global health authorities and respond to queries.
• Oversee authoring, review, and assembly of submission-ready dossiers.
• Track budgets and forecast expenditures, reporting to leadership.

Skills

Regulatory knowledge

Project management

Communication

Attention to detail

Time management

Cross-functional collaboration

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 of Regulatory Project Management to lead global regulatory submissions and drive cross-functional coordination across Clinical, Nonclinical, CMC, Quality, and Commercial teams.

This role emphasizes planning, risk management, and timely regulatory communication with health authorities, ensuring accuracy and audit readiness.