Director of Regulatory Tactics & Submissions

BioSpace; Radnor (Delaware County); On-site; USD 190,000 - 235,000; Full time

Job summary

Immunocore in Gaithersburg, MD (Radnor, PA area) seeks a Director of Regulatory Affairs, Tactical and Implementation to lead the Regulatory Tactical Implementation team. You will standardize processes for efficiency, mentor staff, and guide IND/CTAs, BLAs/MAAs submissions globally.

The role requires strong leadership in biologics regulatory strategy, cross-functional collaboration, and delivery under pressure in a fast-paced development environment. US and EU submissions experience is essential.

Qualifications

• - Solid track record in drug development and leadership within dynamic project teams.
• - Emerging understanding of global regulatory requirements to formulate tactical regulatory strategies.
• - Ability to prepare and submit regulatory documentation to ensure global compliance.
• - Experience proposing regulatory strategies reviewed with management for concurrence.
• - Excellent knowledge of US regulatory requirements with global experience desirable.
• - Experience working cross-functionally within Regulatory Affairs globally.
• - Experience supporting global clinical studies and Health Authorities coordination.
• - Demonstrate agility to accommodate changing priorities and high-profile leadership.

Responsibilities

• Provide regulatory leadership and support to cross-functional development teams to achieve strategic objectives.
• Oversee delivery of US and EU regulatory submission activities across Immunocore portfolio.
• Lead resource planning and training of direct reports in regulatory tactics.
• Input into tactical regulatory strategies aligned with product development plans.
• Manage submission documentation for US and international authorities (CTA/INDs, BLAs/MAAs).
• Serve as centre of excellence for regulatory requirements and conduct regulatory intelligence.
• Assess impact on products and communicate findings; develop procedures and best practices.

Skills

Regulatory leadership

Drug development knowledge

Global regulatory strategy

IND/CTA/BLAs knowledge

Team mentorship

Cross-functional collaboration

Education

Advanced degree (MS/PhD/MD/PharmD)

Job description

Immunocore in Gaithersburg, MD (Radnor, PA area) seeks a Director of Regulatory Affairs, Tactical and Implementation to lead the Regulatory Tactical Implementation team. You will standardize processes for efficiency, mentor staff, and guide IND/CTAs, BLAs/MAAs submissions globally.

The role requires strong leadership in biologics regulatory strategy, cross-functional collaboration, and delivery under pressure in a fast-paced development environment. US and EU submissions experience is essential.