Global Regulatory Affairs Director

BioSpace; 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 biologics, drive IND/CTA submissions, and manage global health authority interactions.

Based in Gaithersburg, MD, Radnor, PA, and Oxford, UK, the role requires strong leadership, cross-functional collaboration, and a track record of successful BLA/MAA filings to support commercialization.

Qualifications

• Experience leading regulatory strategy for late-stage biologics.
• Proven ability to manage IND/CTA/BLAs and MAAs.
• Strong leadership and cross-functional collaboration skills.
• Extensive experience with US FDA and global health authorities.

Responsibilities

• Provide regulatory leadership for IND/CTA submissions and BLA/MAA filings.
• Lead health authority interactions (FDA, EMA, MHRA) and governance reviews.
• Develop and target regulatory strategies to support product development and commercialization.
• Mentor and guide regulatory leads and ensure global consistency.

Skills

Leadership

Regulatory strategy

FDA liaison

Global regulatory

Cross-functional leadership

Education

Advanced degree in science or medicine (MS/PhD/MD/PharmD) or BS with extensive experience

Job description

Immunocore is seeking a Senior Director of Regulatory Affairs to lead regulatory strategy for late-stage biologics, drive IND/CTA submissions, and manage global health authority interactions.

Based in Gaithersburg, MD, Radnor, PA, and Oxford, UK, the role requires strong leadership, cross-functional collaboration, and a track record of successful BLA/MAA filings to support commercialization.