Global Regulatory Lead Director – Biologics Submissions

Immunocore; Oxford (PA); On-site; USD 158,000 - 263,000; Full time

Job summary

Immunocore, a pioneering biotech, invites applications for Director of Regulatory Affairs - Global Regulatory Lead. This full-time role oversees regulatory strategy, IND/CTA submissions, BLA/MAA efforts, and agency interactions across US and international authorities.

You will guide cross‑functional teams, direct submissions, monitor regulatory changes, and liaise with FDA and global health authorities while delivering compliant, timely filings in a high‑pressure, agile environment.

Qualifications

• Solid drug development leadership within a dynamic project team.
• Strong regulatory science background with capability to develop strategies.
• Extensive knowledge of US regulatory requirements and global submissions.

Responsibilities

• Provide regulatory leadership and support to cross-functional development teams to achieve strategic objectives.
• Lead US and ex-US regulatory activities for projects.
• Develop regulatory scientific and tactical plans to support product development.

Skills

Regulatory strategy

IND/CTA/BLAs

FDA liaison

Global regs

Leadership

Cross-functional

Communication

Education

Advanced degree (MS/PhD or MD)

Tools

eCTD exposure

Job description

Immunocore, a pioneering biotech, invites applications for Director of Regulatory Affairs - Global Regulatory Lead. This full-time role oversees regulatory strategy, IND/CTA submissions, BLA/MAA efforts, and agency interactions across US and international authorities.

You will guide cross‑functional teams, direct submissions, monitor regulatory changes, and liaise with FDA and global health authorities while delivering compliant, timely filings in a high‑pressure, agile environment.