Global Regulatory Programs Lead, Immunology

Biopharma Asia; Pennsylvania; On-site; USD 112,000 - 181,000; Full time

Job summary

Johnson & Johnson is seeking a Senior Analyst, Regulatory Program Management – Immunology, located across multiple sites in the US and abroad. You will drive program delivery, coordinate regulatory strategy, and lead cross-functional teams to ensure high-quality submissions and efficient launches.

The role requires 4+ years in pharma/MedTech with strong project management, regulatory knowledge, and collaboration skills. Domestic/international travel up to 10% is expected.

Qualifications

• Minimum of 4 years of industry/business experience in pharma/MedTech or comparable R&D area.
• 2+ years of project leadership across cross-functional teams.
• Proficiency in project management standards, planning and visualization tools.
• Experience conducting business process, scenario and critical path analysis.
• Strong verbal and written communication skills essential.
• Up to 10% travel domestically and internationally.

Responsibilities

• Serve as key facilitator within the RPM department for assigned service area.
• Lead change management and system rollout across RPM team.
• Coordinate health authority meetings, submissions and launch strategy.
• Translate regulatory requirements into executable plans with risk mitigation.
• Provide operational leadership to Regulatory and program teams.
• Support and facilitate GRT meetings and cross-functional collaboration.
• Drive process improvements and embed best practices across programs.

Skills

Project management

Cross-functional leadership

Regulatory knowledge

Verbal & written communication

Strategic thinking

Travel readiness

Education

Bachelor's degree

Advanced degree preferred

Tools

Veeva platform

Microsoft Project

Planisware

Job description

Johnson & Johnson is seeking a Senior Analyst, Regulatory Program Management – Immunology, located across multiple sites in the US and abroad. You will drive program delivery, coordinate regulatory strategy, and lead cross-functional teams to ensure high-quality submissions and efficient launches.

The role requires 4+ years in pharma/MedTech with strong project management, regulatory knowledge, and collaboration skills. Domestic/international travel up to 10% is expected.