Director of Regulatory Affairs,Tactical and Implementation
Immunocore
August 24, 2026
Remote friendly (Radnor, PA)
United States
Corporate Functions
Responsibilities:
- Lead and oversee the Regulatory Tactical Implementation team; standardize processes to improve efficiency, flexibility, and consistency.
- Mentor team members; assign projects with Global Regulatory Leads and VP Regulatory based on priorities/workload and expertise.
- Provide regulatory expertise to development programs, including regulatory implementation of regulatory strategies; IND (development/submission/maintenance/tracking); BLA/sBLA planning/submission/maintenance/tracking; agency liaison for tactical assignments; and regulatory intelligence for requirement changes.
- Oversee tactical implementation of global regulatory submissions to health authorities (e.g., US/EU).
- Manage submission documentation for CTA/IND, BLAs/MAAs, CTA safety reports/updates and other submissions with Global Regulatory Leads and Regulatory Operations.
- Act as global regulatory requirements center of excellence; assess product/process impact and communicate findings.
- Contribute to procedures and working practices; demonstrate leadership, critical thinking, problem-solving, and compliance alignment.
Qualifications (Essential):
- Solid track record in drug development and leadership in dynamic project teams.
- Understanding of global regulatory requirements to formulate tactical strategies; ability to prepare/submit compliant regulatory documentation.
- Excellent US regulatory knowledge and submission experience (global experience desirable).
- Cross-functional/global regulatory affairs experience; experience supporting global clinical studies.
- Ability to work with Health Authorities at project manager level; agility with changing priorities; strong communication and interpersonal skills.
Qualifications (Preferred):
- Experience managing/submitting INDs/CTAs, BLAs/NDAs, MAAs; contribution to at least one NME BLA/NDA desirable.
- Experience supporting FDA health authority meetings.
- Coaching/mentoring regulatory staff.
Education: Advanced degree preferred (M.S., PharmD, Ph.D., M.D.); or BS with 8–10 years’ experience.
US Salary Range: $189,500–$235,000.
- Lead and oversee the Regulatory Tactical Implementation team; standardize processes to improve efficiency, flexibility, and consistency.
- Mentor team members; assign projects with Global Regulatory Leads and VP Regulatory based on priorities/workload and expertise.
- Provide regulatory expertise to development programs, including regulatory implementation of regulatory strategies; IND (development/submission/maintenance/tracking); BLA/sBLA planning/submission/maintenance/tracking; agency liaison for tactical assignments; and regulatory intelligence for requirement changes.
- Oversee tactical implementation of global regulatory submissions to health authorities (e.g., US/EU).
- Manage submission documentation for CTA/IND, BLAs/MAAs, CTA safety reports/updates and other submissions with Global Regulatory Leads and Regulatory Operations.
- Act as global regulatory requirements center of excellence; assess product/process impact and communicate findings.
- Contribute to procedures and working practices; demonstrate leadership, critical thinking, problem-solving, and compliance alignment.
Qualifications (Essential):
- Solid track record in drug development and leadership in dynamic project teams.
- Understanding of global regulatory requirements to formulate tactical strategies; ability to prepare/submit compliant regulatory documentation.
- Excellent US regulatory knowledge and submission experience (global experience desirable).
- Cross-functional/global regulatory affairs experience; experience supporting global clinical studies.
- Ability to work with Health Authorities at project manager level; agility with changing priorities; strong communication and interpersonal skills.
Qualifications (Preferred):
- Experience managing/submitting INDs/CTAs, BLAs/NDAs, MAAs; contribution to at least one NME BLA/NDA desirable.
- Experience supporting FDA health authority meetings.
- Coaching/mentoring regulatory staff.
Education: Advanced degree preferred (M.S., PharmD, Ph.D., M.D.); or BS with 8–10 years’ experience.
US Salary Range: $189,500–$235,000.