Senior Regulatory Program Analyst – Immunology

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

Benefits offered by this job

Vacation – 120 hours per year

Sick time – 40 hours per year

Holiday pay – 13 days per year

Parental Leave – 480 hours per year

Caregiver Leave – 80 hours in 52 weeks

Job summary

Johnson & Johnson is seeking a Senior Analyst, Regulatory Program Manager – Immunology to drive forward regulatory strategy and executable plans across multiple sites, including the US. You will lead cross-functional teams, translate strategy into action, and support health authority submissions while enabling rapid decision-making and delivery.

The role requires 4+ years in the field, strong PM skills, and ability to influence without formal authority.

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 in Pharmaceutical/MedTech R&D.
• Project management experience leading cross-functional teams in a matrix setting.
• High proficiency with project management standards, planning and visualization tools.
• Demonstrated experience conducting business process, scenario, and critical path analysis.
• Excellent verbal and written communication skills.
• Strong innovative and strategic thinking skills.
• Ability to resolve controversy and influence teams without formal authority.
• Up to 10% domestic and international travel.

Responsibilities

• Serve as key facilitator within the RPM department to assigned service area to ensure visibility to book of work and quality.
• Act as change management and implementation leader for new process and system rollout across RPM team.
• Lead operations with Global Regulatory Team (GRT), including health authority meeting planning and worldwide submissions.
• Translate regulatory requirements and strategy into executable plans with detailed steps.
• Provide operational leadership to Regulatory and program teams with scenario visualization for rapid decision making.
• Support the Global Regulatory Team (GRT) and facilitate GRT meetings and related activities.
• Coordinate regulatory information and communications to align with strategy and status.
• Lead operational execution of select marketing applications and alignment with submission strategies.
• Drive process improvements and embed best practices across programs.
• Work across functions to establish processes and new methods improving delivery.
• Build RPM value proposition and enhance capabilities across the portfolio.
• Assist budgeting/forecasting tools to build regulatory components into the overall plan.

Skills

Project management

Verbal and written communication

Strategic thinking

Influence without authority

Education

Bachelor’s degree

Advanced degree

Tools

Veeva platform

Microsoft Project (Server/Online)

Job description

Johnson & Johnson is seeking a Senior Analyst, Regulatory Program Manager – Immunology to drive forward regulatory strategy and executable plans across multiple sites, including the US. You will lead cross-functional teams, translate strategy into action, and support health authority submissions while enabling rapid decision-making and delivery.

The role requires 4+ years in the field, strong PM skills, and ability to influence without formal authority.