Global Regulatory Lead - Biologics Strategy & Submissions

Immunocore; Gaithersburg (MD); On-site; USD 180,000 - 260,000; Full time

Job summary

Immunocore seeks a Director of Regulatory Affairs to lead regulatory strategy across multiple programs in Gaithersburg, MD; Radnor, PA; and Oxford, UK. You will drive IND/CTA, BLA/NDA submissions, and FDA interactions, coordinating with global teams to ensure compliant, timely filings.

This role requires extensive biologics regulatory expertise and decisive leadership in a fast-paced setting. You will oversee regulatory planning, submit documents, monitor global requirements, and mentor teams to

Qualifications

• Solid track record in drug development and leadership within a dynamic project team.
• Strong understanding of global regulatory requirements for regulatory strategies.
• Excellent knowledge of US regulatory requirements with submissions experience.
• Experience in supporting global clinical studies.
• Experience submitting INDs/CTAs, BLAs/NDAs, and MAAs; at least 1 NME BLA/NDA desirable.
• Experience in Health Authority Meetings and liaison with FDA and global authorities.
• Demonstrate agility to adapt to changing priorities.
• Proven leadership with strong communication and interpersonal skills.

Responsibilities

• Provide regulatory leadership to cross-functional development project teams to achieve strategic objectives.
• Responsible for US and ex-US regulatory activities for the project teams.
• Develop regulatory scientific and tactical plans and target labelling for product development.
• Lead creation of regulatory submission documents (IND/CTA, CTD/BLA/MAA) for eCTD submissions.
• Manage submission of regulatory documentation to US and international authorities.
• Act as center of excellence for global regulatory requirements, especially US; monitor regulatory environment.
• Contribute to procedures and practices for late-stage development and commercialization.
• Oversee regulatory review of clinical trial labelling and CMC submissions with the Director of Regulatory CMC.
• Demonstrate professionalism, leadership, critical thinking, and data-supported conclusions.
• Review and ensure the quality of detailed scientific information with adequate evidence.

Skills

Drug development leadership

Global regulatory knowledge

US regulatory knowledge

Global clinical studies

IND/CTA/BL/NDA/MAA submissions

Health Authority meetings

Agility

Leadership & communication

Education

Advanced degree preferred

BS with 8-12 years experience

Job description

Immunocore seeks a Director of Regulatory Affairs to lead regulatory strategy across multiple programs in Gaithersburg, MD; Radnor, PA; and Oxford, UK. You will drive IND/CTA, BLA/NDA submissions, and FDA interactions, coordinating with global teams to ensure compliant, timely filings.

This role requires extensive biologics regulatory expertise and decisive leadership in a fast-paced setting. You will oversee regulatory planning, submit documents, monitor global requirements, and mentor teams to