Senior Regulatory Program Lead – Immunology

Johnson & Johnson Co.; Horsham (PA); On-site; USD 112,000 - 181,000; Full time

Benefits offered by this job

Vacation time 120 hours/yr

Sick time 40-56 hours/yr

Floating holidays 13 days/yr

Job summary

Johnson & Johnson Innovative Medicine seeks a Senior Analyst, Regulatory Program Manager – Immunology to locations including Spring House, Horsham, and other U.S. sites.

This role leads cross-functional regulatory work, drives strategic execution, and coordinates with Global Regulatory Affairs and Medical Writing to advance immunology programs. The position requires a bachelor’s degree (advanced degree preferred), 4+ years in pharma/MedTech with project management experience, and travel up to

Qualifications

• Minimum of a Bachelor’s degree is required.
• Advanced degree is preferred.
• Minimum of 4 years of industry/business experience with at least 2 years of experience in a Pharmaceutical, MedTech or comparable R&D area.
• Project management experience leading cross-functional teams in a matrix setting.
• High proficiency in project management standards, planning and visualization tools.
• Must have excellent verbal and written communication skills.
• Must have strong innovative and strategic thinking skills.
• Ability to resolve controversy and influence teams without formal authority.

Responsibilities

• Serve as key facilitator within the RPM department to assigned service area to help ensure proper visibility to book of work, monitoring quality and process to support the success of the RPM department.
• Function as a change management and implementation leader for new process and system rollout across RPM team.
• Lead operations with Global Regulatory Team (GRT), including activities such as health authority meeting planning, worldwide submissions, driving processes to optimize global filing and launch strategy.
• Translate regulatory requirements and strategy into an executable plan at a level of detail that allows teams to understand what is critical at any one time, proactively identify and mitigate risks, and exploit meaningful opportunities for acceleration.
• Provide strong operational leadership to Regulatory and program teams, providing scenario and visualization support driving rapid and informed decision making.
• Support the Global Regulatory Team (GRT) in a manner that fosters and maintains a high-performance team culture, facilitating meetings and governance as required.
• Lead the operational execution of select marketing applications including clinical variations and Pediatric submissions, aligning Regulatory and compound submission strategies.
• Drive process improvements and embed best practices from across programs, TA’s and functions into supported teams.
• Work across functions to establish processes and procedures and new methods that improve delivery.
• Build RPM value proposition through continuous refinement of delivery and capability enhancements.

Skills

Project management

Cross-functional teamwork

Regulatory knowledge

Communication skills

MS Project

Veeva

Education

Bachelor's degree

Advanced degree preferred

Tools

Veeva

Planisware

Microsoft Project

Job description

Johnson & Johnson Innovative Medicine seeks a Senior Analyst, Regulatory Program Manager – Immunology to locations including Spring House, Horsham, and other U.S. sites.

This role leads cross-functional regulatory work, drives strategic execution, and coordinates with Global Regulatory Affairs and Medical Writing to advance immunology programs. The position requires a bachelor’s degree (advanced degree preferred), 4+ years in pharma/MedTech with project management experience, and travel up to