Global Regulatory Affairs Director: Strategic Submissions

Immunocore Ltd.; Radnor (Delaware County); On-site; USD 190,000 - 235,000; Full time

Job summary

Immunocore Ltd. seeks a Director of Regulatory Affairs, Tactical and Implementation to lead a fast-moving Regulatory Tactical Implementation team in Gaithersburg/PA. You will steer regulatory strategies, oversee submissions and provide liaison with US/EU authorities while mentoring staff and aligning with Global Regulatory Leads.

Ideal candidates have strong leadership, Biologics experience, and proven ability to operate in an agile, entrepreneurial environment under pressure.

Qualifications

• Experience leading regulatory teams in biologics and drug development.
• Proven ability to prepare and submit regulatory documentation globally.
• Strong knowledge of US/EU regulatory requirements and agency liaison.
• Ability to lead strategic regulatory initiatives with senior management.

Responsibilities

• Provide leadership for the Regulatory Tactical Implementation team.
• Oversee US/EU regulatory submission activities across Immunocore portfolio.
• Mentor team members and assign projects based on priorities and expertise.
• Coordinate IND/CTA/BLAs and ensure timely submissions and updates.
• Provide regulatory intelligence on changes in laws and guidelines.

Skills

Regulatory strategy

IND/CTA submissions

Global regulatory requirements

Education

Advanced degree preferred (MS/PhD/MD/PharmD)

BS with substantial regulatory experience

Job description

Immunocore Ltd. seeks a Director of Regulatory Affairs, Tactical and Implementation to lead a fast-moving Regulatory Tactical Implementation team in Gaithersburg/PA. You will steer regulatory strategies, oversee submissions and provide liaison with US/EU authorities while mentoring staff and aligning with Global Regulatory Leads.

Ideal candidates have strong leadership, Biologics experience, and proven ability to operate in an agile, entrepreneurial environment under pressure.