Director, Global Regulatory Strategy & Submissions

Immunocore; Gaithersburg, Northern (MD, KY); Hybrid; USD 158,000 - 263,000; Full time

Job summary

Immunocore seeks a Director of Regulatory Affairs, Tactical and Implementation to lead the regulatory tactical implementation team across US and EU submissions. You will mentor staff, coordinate strategies, and collaborate with Global Regulatory Leads to ensure timely, compliant fillings for Immunocore's development programs.

The ideal candidate has significant drug development and regulatory leadership experience, with the ability to operate in a fast-paced, cross-functional environment and

Qualifications

• Solid track record in drug development and leadership within a dynamic project team.
• Emerging understanding of global regulatory requirements to formulate tactical regulatory strategies.
• Experience in preparing and submitting regulatory documentation for global compliance.
• Advanced degree preferred; BS with 8-10 years of experience also acceptable.

Responsibilities

• Provide regulatory leadership for US and EU submissions across Immunocore portfolio.
• Lead resource planning and training of direct reports.
• Coordinate submission documentation supporting regulatory submissions to US and other authorities.
• Act as center of excellence for global regulatory requirements and conduct regulatory intelligence.
• Contribute to regulatory strategy and alignment with Global Regulatory Leads and Regulatory Operations.
• Supervise and mentor regulatory staff, guiding priority and workload management.

Skills

Leadership

Regulatory strategy

Regulatory submissions

Mentoring

Cross-functional collaboration

Education

Advanced degree (MS/PharmD/PhD/MD)

BS with 8-10 years experience

Job description

Immunocore seeks a Director of Regulatory Affairs, Tactical and Implementation to lead the regulatory tactical implementation team across US and EU submissions. You will mentor staff, coordinate strategies, and collaborate with Global Regulatory Leads to ensure timely, compliant fillings for Immunocore's development programs.

The ideal candidate has significant drug development and regulatory leadership experience, with the ability to operate in a fast-paced, cross-functional environment and