Global Regulatory Director, Biologics & Late-Stage

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

Job summary

Immunocore seeks a Senior Director of Regulatory Affairs to lead regulatory strategy across global programs, including interactions with FDA and other authorities. The role mandates a strong track record in biologics and late-stage submissions, with leadership across cross-functional teams.

The candidate will guide IND/CTA submissions, BLA/ NDA processes, and health authority engagements, shaping regulatory science to enable clinical development and commercialization.

Qualifications

• Advanced degree in life sciences or medicine preferred.
• 10+ years regulatory affairs experience in biotech/pharma.
• Experience leading regulatory strategies across US, EU and global health authorities.

Responsibilities

• Provide regulatory leadership for development programs and governance reviews.
• Develop regulatory strategies and labeling targets for products.
• Lead preparation/writing of INDs, CTAs, BLAs/NDAs and MAAs for global submissions.
• Manage health authority interactions (FDA, EMA, MHRA) and strategic planning.
• Mentor and oversee regulatory team members and cross-functional partners.

Skills

Drug development

Regulatory leadership

Global regulatory

FDA liaison

Cross-functional collaboration

Education

Advanced degree preferred

BS with experience

Tools

IND/CTA submissions

BLA/NDA/MAA submissions

eCTD submissions

Job description

Immunocore seeks a Senior Director of Regulatory Affairs to lead regulatory strategy across global programs, including interactions with FDA and other authorities. The role mandates a strong track record in biologics and late-stage submissions, with leadership across cross-functional teams.

The candidate will guide IND/CTA submissions, BLA/ NDA processes, and health authority engagements, shaping regulatory science to enable clinical development and commercialization.