Senior Director, Regulatory Affairs - Oncology

Hamlyn Williams; United States; Remote; USD 250,000 - 270,000; Full time

Job summary

A leading company in the pharmaceutical industry seeks a Senior Director of Regulatory Affairs to shape regulatory strategies for oncology programs. This pivotal role involves leading a team, crafting submissions, and ensuring compliance with FDA regulations to accelerate drug development. The ideal candidate will possess extensive experience in regulatory affairs and strong leadership skills, with a passion for innovation in healthcare.

Qualifications

• 10+ years of experience in the pharmaceutical industry, with 8+ years in US regulatory affairs.
• Proven experience leading regulatory submissions and managing FDA interactions.

Responsibilities

• Design and implement US regulatory strategies for assigned projects.
• Lead the preparation and submission of regulatory filings.
• Mentor and provide strategic guidance to a team of US Regulatory Strategists.

Skills

Leadership

Communication

Collaboration

Education

Bachelor’s degree in chemistry, biology, or a related field

Advanced degree (PharmD, PhD, or Master’s)

Job description

Senior Director, Regulatory Affairs - Oncology

Senior Director, Regulatory Affairs - Oncology

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Location: New Jersey, US or Remote (EST)

About the Company:

Our client is a globally recognized pharmaceutical leader committed to advancing groundbreaking therapies that address critical and underserved medical needs. With a legacy of scientific excellence and a presence spanning multiple continents, they are dedicated to transforming patient outcomes through cutting-edge research and life-changing healthcare solutions. Their focus includes oncology, rare diseases, and immune disorders - driving medical innovation where it matters most.

About the Role:

As a Senior Director of Regulatory Affairs, you will play a pivotal role in shaping the regulatory strategy for high-profile development programs, guiding them from early-stage research through FDA approval. Leading a team of US Regulatory Strategists, you will provide expert mentorship, develop innovative regulatory approaches, and serve as the primary liaison with the FDA to ensure streamlined pathways to market.

In this high-impact leadership role, you will craft persuasive submissions, negotiate regulatory strategies, and drive compliance while identifying opportunities to accelerate drug development. By fostering cross-functional collaboration, you will establish best practices that enhance efficiency, transparency, and overall program success - ultimately bringing transformative therapies to patients faster.

Key Responsibilities:

• Design and implement US regulatory strategies for assigned projects, ensuring alignment with organizational objectives.
• Lead the preparation and submission of regulatory filings, including briefing documents, breakthrough therapy requests, orphan drug applications, and BLA annual reports.
• Plan and execute FDA interactions, including meeting preparation, negotiation, and documentation of outcomes.
• Lead, mentor, and provide strategic guidance to a team of US Regulatory Strategists, ensuring alignment with development goals and regulatory requirements while fostering professional growth and operational excellence.
• Represent US regulatory affairs in global product team meetings, providing strategic input and managing day-to-day activities.
• Identify and address risks or misalignments, escalating issues to senior leadership with actionable solutions.
• Stay informed on evolving regulatory guidelines and industry trends through continuous learning and professional development.

Qualifications:

• Bachelor’s degree in chemistry, biology, or a related field (required).
• Advanced degree (PharmD, PhD, or Master’s) in a relevant discipline (preferred).
• 10+ years of experience in the pharmaceutical industry, with 8+ years in US regulatory affairs.
• Proven experience leading regulatory submissions and managing FDA interactions.
• Strong leadership, communication, and collaboration skills.
• Ability to travel up to 20% as needed

This is a rare opportunity to take ownership of critical regulatory initiatives, influence high-impact programs, and accelerate life-changing treatments to market. If you’re a strategic regulatory leader with a passion for innovation, we invite you to apply.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science and Strategy/Planning

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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