Hybrid Senior Regulatory Program Manager, Immunology

Biopharma Asia; Maidenhead; Hybrid; GBP 90,000 - 130,000; Full time

Job summary

Johnson & Johnson Innovative Medicine seeks a Senior Analyst, Regulatory Program Management – Immunology. Location options include multiple U.S. sites and international postings, with visa sponsorship not provided.

The role drives delivery of regulatory plans for immunology programs, coordinating cross-functional teams and ensuring timely, compliant submissions while guiding process improvements and risk management.

Qualifications

• Bachelor’s degree required; advanced degree preferred.
• Experience in pharmaceutical/biotech regulatory environments is essential.
• Strong project management and cross-functional leadership skills.

Responsibilities

• Serve as key facilitator within the RPM department to assigned service area.
• Lead change management and implementation for new processes and system rollouts.
• Coordinate health authority planning, submissions, and launch strategy.
• Translate regulatory requirements into executable plans with risk assessments.
• Provide operational leadership to regulatory and program teams.
• Support GRT meetings and cross-functional communications.
• Drive process improvements and best-practices across programs.

Skills

Project management

Stakeholder communication

Cross-functional collaboration

Regulatory knowledge

Risk assessment

Process improvement

Education

Bachelor's degree

Advanced degree preferred

Tools

Veeva Systems

Microsoft Project

Planisware

Job description

Johnson & Johnson Innovative Medicine seeks a Senior Analyst, Regulatory Program Management – Immunology. Location options include multiple U.S. sites and international postings, with visa sponsorship not provided.

The role drives delivery of regulatory plans for immunology programs, coordinating cross-functional teams and ensuring timely, compliant submissions while guiding process improvements and risk management.