Global Regulatory Lead Director — Biologics (Remote)

BioSpace; Gaithersburg (MD); Remote; USD 190,000 - 235,000; Full time

Job summary

Immunocore seeks a Director of Regulatory Affairs to lead global regulatory strategy across development programs, including IND/CTA, BLA/MAA submissions, and FDA interactions. This role oversees US and international submissions and coordinates with global sites to ensure compliant, timely filings.

The successful candidate will bring a strong biologics background, strategic leadership, and the ability to operate in a fast-paced, entrepreneurial environment while delivering regulatory guidance

Qualifications

• Solid track record in drug development and leadership within a dynamic project team(s).
• Strong understanding of global regulatory requirements to form regulatory strategies.
• Excellent knowledge of US regulatory requirements and submissions experience.

Responsibilities

• Provide regulatory leadership to cross-functional development teams to achieve strategic objectives.
• Be responsible for US and ex-US regulatory activities associated with project teams.
• Develop regulatory scientific and tactical plans and target labelling to support product development.
• Lead drafting and submission of INDs/CTAs, BLAs, NDAs, and MAAs, including eCTD documents.
• Liaise with FDA and global Health Authorities; monitor regulatory environment for relevant therapies.

Skills

Regulatory leadership

Global regulatory strategy

IND/CTA/BLA submissions

FDA liaison

Education

Advanced degree

Job description

Immunocore seeks a Director of Regulatory Affairs to lead global regulatory strategy across development programs, including IND/CTA, BLA/MAA submissions, and FDA interactions. This role oversees US and international submissions and coordinates with global sites to ensure compliant, timely filings.

The successful candidate will bring a strong biologics background, strategic leadership, and the ability to operate in a fast-paced, entrepreneurial environment while delivering regulatory guidance