Regulatory Project Lead — Global Submissions

Socket.dev; 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

Paid time off

Wellness program

Job summary

Centessa Pharmaceuticals, a clinical-stage company, seeks an Associate Director, Regulatory Project Management to lead cross-functional regulatory submissions and programs. You will manage timelines, ensure documentation quality, and drive regulatory strategy and execution across global health authorities.

Successful candidates bring 8+ years in regulatory affairs, strong program management skills, and excellent communication.

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 project management tools (e.g., Microsoft Project, Smartsheet) and methodologies (PMP, PRINCE2, RAC).
• Excellent interpersonal and communication skills to engage stakeholders and drive decisions.
• Analytical and problem-solving abilities to interpret regulatory requirements and translate into tasks.

Responsibilities

• Develop and maintain integrated project plans for regulatory submissions (IND, NDA, BLA, MAA) and post-approval activities.
• Coordinate timelines from Clinical, Nonclinical, CMC, Quality, and Commercial teams to ensure alignment.
• Identify, assess, and mitigate project risks with contingency plans.
• Coordinate with Regulatory Strategy Lead for agency meetings and responses to queries.
• Oversee authoring, review, and assembly of submission dossiers for accuracy and consistency.
• Develop and track budgets and report financial performance to leadership.

Skills

Regulatory knowledge

Project management

Communication skills

Analytical skills

Attention to detail

Education

Bachelor’s degree in a scientific or related field

Tools

Microsoft Project

Smartsheet

PMP

PRINCE2

RAC

Job description

Centessa Pharmaceuticals, a clinical-stage company, seeks an Associate Director, Regulatory Project Management to lead cross-functional regulatory submissions and programs. You will manage timelines, ensure documentation quality, and drive regulatory strategy and execution across global health authorities.

Successful candidates bring 8+ years in regulatory affairs, strong program management skills, and excellent communication.