Global Regulatory Affairs Director, Oncology Leadership

Page Mechanical Group, Inc.; Boston (MA); Hybrid; USD 250,000 - 360,000; Full time

Job summary

AVEO Oncology is seeking an Executive Director, Global Regulatory Affairs to provide strategic and operational leadership for global regulatory activities across the company’s oncology portfolio. You will be accountable for the development and execution of integrated global regulatory strategies from early development through registration and post-approval lifecycle management.

As a senior Regulatory Affairs leader, you will oversee global programs, guide Health Authority engagement strategies

Qualifications

• 15+ years of progressive Regulatory Affairs experience within the pharma/biotech industry, oncology focus preferred.
• Experience leading global regulatory strategies for multiple development programs (Phase 1–4).
• Proven experience interacting with Health Authorities (FDA, EMA) at senior levels.
• Experience negotiating outcomes with FDA/EMA and in oncology/rare diseases.
• Demonstrated ability to develop and mentor senior regulatory leaders in a matrixed environment.

Responsibilities

• Provide executive regulatory leadership for assigned oncology programs across the full product lifecycle.
• Oversee Global Regulatory Leaders for oncology programs and ensure high-quality strategy development across regions.
• Input regulatory strategy into governance, assess risk and mitigation for senior leadership decisions.
• Lead global Health Authority engagement strategies (FDA, EMA, and others) and oversee major interactions.
• Ensure preparation and approval of high-quality regulatory submissions (INDs/CTAs, BLAs/MAAs, labeling).
• Oversee regulatory approaches for CDx, biomarkers, devices, and combination products.

Skills

Regulatory strategy

Leadership

Stakeholder influence

Communication skills

Electronic submissions

Education

Bachelor's degree in Life Sciences

MS/PhD/PharmD/MD or equivalent preferred

Tools

Electronic submission systems

Regulatory information management (RIM) systems

Job description

AVEO Oncology is seeking an Executive Director, Global Regulatory Affairs to provide strategic and operational leadership for global regulatory activities across the company’s oncology portfolio. You will be accountable for the development and execution of integrated global regulatory strategies from early development through registration and post-approval lifecycle management.

As a senior Regulatory Affairs leader, you will oversee global programs, guide Health Authority engagement strategies