Global Regulatory Strategy & Submissions Leader

Immunocore; Radnor (Delaware County); On-site; USD 180,000 - 240,000; Full time

Job summary

Immunocore in Gaithersburg, MD, is seeking a Director of Regulatory Affairs to lead the Tactical Implementation team within Regulatory Affairs. You will mentor staff, assign projects to Global Regulatory Leads, and drive IND/BLA planning and submissions, coordinating with Health Authorities worldwide.

The role requires strong leadership, an ability to operate in an agile, entrepreneurial environment, and experience with US and EU regulatory submissions across development programs.

Qualifications

• Solid track record in drug development and leadership within a dynamic project team(s).
• Emerging understanding of global regulatory requirements to formulate tactical regulatory strategies.
• Ability to prepare and submit regulatory documentation to ensure regulatory compliance globally.
• Emerging ability to propose scientific regulatory strategies reviewed with line management for concurrence and approval.
• Excellent knowledge of US regulatory requirements and experience with submissions in drug development.

Responsibilities

• Provide coaching/skill development and performance feedback for regulatory staff in the tactical implementation group.
• Provide regulatory leadership and support to cross functional development for projects to jointly achieve strategic objectives.
• Oversee delivery of US and EU regulatory submission activities across the Immunocore portfolio.
• Lead resource planning and training of direct reports.
• Input into the implementation of regulatory tactical strategies to support development of products aligned with strategies.
• Manage, prepare, coordinate and be responsible for submission of documentation supporting regulatory submissions to US and international authorities.
• Act as center of excellence for regulatory requirements and conduct regulatory intelligence to anticipate changes in laws and standards.
• Assess impact on products/processes and communicate findings.
• Contribute to establishment and development of procedures and working practices for a company in development.
• Demonstrate professionalism, efficiency and leadership within the team; apply critical thinking and regulatory expertise.

Skills

Leadership

Regulatory leadership

Regulatory strategy

Cross-functional collaboration

Project management

Education

Advanced degree preferred

Job description

Immunocore in Gaithersburg, MD, is seeking a Director of Regulatory Affairs to lead the Tactical Implementation team within Regulatory Affairs. You will mentor staff, assign projects to Global Regulatory Leads, and drive IND/BLA planning and submissions, coordinating with Health Authorities worldwide.

The role requires strong leadership, an ability to operate in an agile, entrepreneurial environment, and experience with US and EU regulatory submissions across development programs.