Director, Global Regulatory Affairs - Biologics

Immunocore; Gaithersburg (MD); On-site; USD 180,000 - 250,000; Full time

Job summary

Immunocore is seeking a Director of Regulatory Affairs to lead the Tactical Implementation team, overseeing US and EU submissions, IND/CTA planning, and regulatory intelligence across global programs. This role drives strategy, mentoring, and cross-functional collaboration in a fast-paced biologics environment.

You will coordinate submissions, liaise with health authorities, manage resources, and ensure compliance while developing a high-performing team with worldwide regulatory experience.

Qualifications

• Experience in drug development and leading cross-functional teams.
• Emerging understanding of global regulatory requirements and regulatory strategy.
• Ability to prepare regulatory submissions (INDs/CTAs, BLAs/NDAs, MAAs).
• Experience with US regulatory requirements and global submissions.

Responsibilities

• Provide coaching and performance feedback to regulatory staff.
• Provide regulatory leadership for cross-functional development to achieve objectives.
• Oversee US/EU regulatory submissions across the Immunocore portfolio.
• Lead resource planning and training of direct reports.
• Input regulatory tactical strategies aligned with product development goals.
• Coordinate submission documentation for US and international regulators.
• Act as center of excellence for regulatory requirements and guidance.

Skills

Talent management

Communication proficiency

Time management

Personal effectiveness

Flexibility

Technical capacity

Stress management

Leadership

Education

Advanced degree (MS/PhD/MD) or PharmD

Job description

Immunocore is seeking a Director of Regulatory Affairs to lead the Tactical Implementation team, overseeing US and EU submissions, IND/CTA planning, and regulatory intelligence across global programs. This role drives strategy, mentoring, and cross-functional collaboration in a fast-paced biologics environment.

You will coordinate submissions, liaise with health authorities, manage resources, and ensure compliance while developing a high-performing team with worldwide regulatory experience.