Global Regulatory Chief for Gene Editing Therapies

Editas Medicine; Cambridge (MA); Hybrid; USD 345,000 - 372,000; Full time

Benefits offered by this job

Blue Cross Blue Shield PPO MedicalPlan

Health Savings Account

Dental and Vision Insurance

Life and Disability Insurance

Tuition Reimbursement

401(k) plan with company match

Employee Assistance Plan

Wellness Programs

Paid Time Off policy

Job summary

Editas Medicine is seeking a Vice President, Regulatory Affairs to lead the global regulatory function for in vivo gene editing therapies. You will partner with executive leadership, oversee submissions from development through marketing authorization, and shape evidence-generation strategies across complex regulatory landscapes.

Ideal candidates bring 15+ years in biotech/pharma Regulatory Affairs, direct global submissions experience, and a track record of guiding programs from preclinical to

Qualifications

• 15+ years in biotech/pharma Regulatory Affairs.
• Experience as senior regulatory professional in a small/ emerging company.
• Experience authoring and assembling major submission documents.

Responsibilities

• Define and execute an integrated global regulatory strategy across the portfolio.
• Lead regulatory strategy from preclinical to registrational development; INDs/CTAs; approvals.
• Provide regulatory recommendations and risk-mitigation plans to governance bodies.

Skills

Regulatory strategy leadership

Global regulatory affairs

FDA/health authority interactions

Executive communication

Cross-functional collaboration

Education

Advanced degree in science/medical/pharmacy/engineering

Tools

eCTD submission tools

Job description

Editas Medicine is seeking a Vice President, Regulatory Affairs to lead the global regulatory function for in vivo gene editing therapies. You will partner with executive leadership, oversee submissions from development through marketing authorization, and shape evidence-generation strategies across complex regulatory landscapes.

Ideal candidates bring 15+ years in biotech/pharma Regulatory Affairs, direct global submissions experience, and a track record of guiding programs from preclinical to