Global Regulatory Strategy Director (IND/BLA Lead)

Immunocore; Radnor (Delaware County); On-site; USD 250,000 - 270,000; Full time

Job summary

Immunocore is seeking a Senior Director of Regulatory Affairs to lead regulatory strategy for late-stage programs and coordinate worldwide submissions. You will drive IND/CTA and BLA/NDA activities, liaise with FDA and global health authorities, and guide governance meetings.

You will mentor regulatory leads, shape cross‑functional plans, and ensure compliance across development programs while collaborating with internal teams and external partners.

Qualifications

• Extensive experience leading regulatory strategy for late-stage drug development.
• Proven ability to manage INDs/CTAs, BLA/NDA submissions and global health authority interactions.
• Strong leadership, communication, and cross functional collaboration.

Responsibilities

• Provide regulatory leadership for development programs, guiding strategy and submissions.
• Oversee health authority interactions globally and liaise with FDA and other agencies.
• Mentor and supervise regulatory leads and ensure alignment across projects.
• Prepare and review regulatory submission documents and labeling.
• Ensure compliance and align regulatory plans with governance.

Skills

Regulatory strategy

Global regulatory leadership

Health Authority liaison

IND/CTA/BLA/NDA submissions

Drug development leadership

Education

Advanced degree (M.S., PharmD, Ph.D., or M.D.)

Job description

Immunocore is seeking a Senior Director of Regulatory Affairs to lead regulatory strategy for late-stage programs and coordinate worldwide submissions. You will drive IND/CTA and BLA/NDA activities, liaise with FDA and global health authorities, and guide governance meetings.

You will mentor regulatory leads, shape cross‑functional plans, and ensure compliance across development programs while collaborating with internal teams and external partners.