Senior Regulatory Project Manager - Global Submissions

Centessa Pharmaceuticals; 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

Health and wellness program

Job summary

Centessa Pharmaceuticals in Boston seeks an Associate Director of Regulatory Project Management to lead regulatory projects across development programs. You will own timelines, ensure compliant submissions to health authorities, and partner with Clinical, Nonclinical, CMC, Quality, and Commercial teams to align milestones and resources.

This role requires 8+ years in regulatory affairs, strong planning and communication skills, and proficiency with PM tools.

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 in relevant industries
• Proficiency in project management tools (e.g., Microsoft Project, Smartsheet) and methodologies (PMP, PRINCE2, RAC)
• 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
• Analytical and problem-solving abilities to interpret regulatory requirements and translate them into actionable tasks
• Attention to detail for accurate documentation and regulatory compliance

Responsibilities

• Develop and maintain integrated regulatory submission plans (IND, NDA, BLA, MAA) and post-approval activities.
• Coordinate timelines with Clinical, Nonclinical, CMC, Quality, and Commercial functions.
• Identify, assess, and mitigate project risks with contingency plans.
• Coordinate with Regulatory Strategy Lead for global agency interactions and meetings.
• Oversee authoring, review, and assembly of submission-ready dossiers.
• Develop and track budgets, forecast expenditures, and report financial performance to leadership

Job description

Centessa Pharmaceuticals in Boston seeks an Associate Director of Regulatory Project Management to lead regulatory projects across development programs. You will own timelines, ensure compliant submissions to health authorities, and partner with Clinical, Nonclinical, CMC, Quality, and Commercial teams to align milestones and resources.

This role requires 8+ years in regulatory affairs, strong planning and communication skills, and proficiency with PM tools.