Global Oncology Regulatory Strategy Director

Discover International; Boston (MA); On-site; USD 180,000 - 260,000; Full time

Job summary

Discover International is seeking a Director, Global Regulatory Affairs — Oncology to lead regulatory strategy and execution for oncology programs. You will partner with global clinical development teams to navigate milestones, submissions, and lifecycle activities.

The ideal candidate has 6+ years in regulatory affairs, strong oncology experience, and proven FDA/EMA interactions, with the ability to influence cross-functional teams in a complex matrix environment.

Qualifications

• 6+ years of regulatory affairs experience in pharma/biotech.
• 3+ years of oncology regulatory experience.
• Experience interacting with major health authorities (FDA/EMA).
• Experience leading global regulatory strategies.
• Ability to lead cross-functional teams in a matrixed organization.
• Excellent written and verbal English communication.

Responsibilities

• Develop and execute global regulatory strategies for oncology programs.
• Lead regulatory submission planning and execution across regions.
• Serve as regulatory representative in FDA/EMA interactions.
• Provide strategic regulatory guidance to clinical development and portfolio teams.
• Assess regulatory risks and translate requirements into actionable plans.
• Lead cross-functional teams to align development plans and submission deliverables.
• Prepare for health authority meetings and regulatory milestones.
• Contribute to lifecycle planning including new indications.
• Mentor regulatory colleagues and promote proactive risk management.

Skills

Regulatory strategy

Cross-functional leadership

FDA/EMA interactions

English communication

Regulatory strategy execution

Education

Advanced degree (PharmD/MD/PhD)

Tools

eCTD submissions

Job description

Discover International is seeking a Director, Global Regulatory Affairs — Oncology to lead regulatory strategy and execution for oncology programs. You will partner with global clinical development teams to navigate milestones, submissions, and lifecycle activities.

The ideal candidate has 6+ years in regulatory affairs, strong oncology experience, and proven FDA/EMA interactions, with the ability to influence cross-functional teams in a complex matrix environment.