Director of Regulatory Affairs,Tactical and Implementation

About the role

The Director of Regulatory Affairs will lead and oversee the Regulatory Tactical Implementation team within Regulatory Affairs. They will provide leadership for process standardization to enhance efficiency, flexibility, and consistency across projects. They will mentor team members and make project assignments with Global Regulatory Leads and the VP of Regulatory based on priorities and expertise.

Responsibilities

• Leadership and oversight of the Regulatory Tactical Implementation team
• Mentorship and project assignment coordination with Global Regulatory Leads and VP of Regulatory
• Expertise provision for Immunocore's development programs, including regulatory strategy implementation, IND development/submission/maintenance/tracking, BLA/sBLA planning/submission/maintenance/tracking, agency liaison, and regulatory intelligence for process-related changes
• Interacting with global sites, both in-house and outsourced
• Overseeing global regulatory submissions to Health Authorities
• Coaching and skill development for regulatory staff
• Supporting cross-functional development teams to achieve strategic objectives
• Leading resource planning and training of direct reports
• Contributing to regulatory tactical strategies to support product development
• Managing, preparing, coordinating, and being responsible for regulatory submission documentation
• Conducting regulatory intelligence to anticipate changes in laws, guidance, and standards impacting tactical implementation
• Assessing the impact of regulatory changes on products and processes and communicating findings
• Establishing and developing procedures and working practices aligned with regulatory requirements
• Demonstrating professionalism, efficiency, and leadership within the team while demonstrating critical thinking, effective problem-solving, and a strong knowledge of regulatory strategies
• Supervising regulatory affairs staff, including identifying skill development opportunities

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 that are reviewed with line management for concurrence and approval
• Excellent knowledge of US regulatory requirements and experience with submissions gained within drug development
• Global experience desirable
• Experience in working cross-functionally and globally within Regulatory Affairs
• Experience in supporting global clinical studies and Health Authorities
• Proven leadership, excellent communication, and interpersonal skills