Senior Analyst, Regulatory Program Management - Immunology

About the role

Johnson & Johnson is looking for a Senior Analyst, Regulatory Program Management (RPM) for its Innovative Medicine Immunology portfolio. The role is an operational leader who ensures visibility of the workload, assesses processes, monitors quality and acts as a change management and implementation leader for new processes and systems. It is based in Allschwil, Basel, and candidates must already hold work authorization in the country of employment.

Key responsibilities

• Facilitate the RPM service area, monitor quality and process, and act as a change management and implementation leader for new processes and systems.
• Lead operations with the Global Regulatory Team, including health authority meeting planning, worldwide submissions, global filing and launch strategy, and pre- and post-submission activities.
• Translate regulatory requirements and strategy into executable plans, identify and mitigate risks and accelerate delivery (e.g., project plans, risk and opportunity playbooks).
• Support the Global Regulatory Team and its working groups, and share regulatory information and status with partners.
• Lead the execution of marketing applications, clinical variations and pediatric submissions, and drive process improvements across programs.
• Work with budgeting and forecasting tools to maintain regulatory budgets and project plans in Planisware, and support resource and cost planning.

Required profile

• Minimum Bachelor's degree; advanced degree preferred.
• At least 4 years of industry experience, including 2 years in pharmaceutical, MedTech or comparable R&D.
• Project management experience leading cross-functional teams in a matrix setting.
• Experience in business process, scenario and critical path analysis.
• Excellent verbal and written communication, and ability to influence teams without formal authority.
• Up to 10% domestic and international travel; no immigration sponsorship or relocation support.

Required skills

• High proficiency in project management standards, planning and visualization tools.
• Preferred: knowledge of global regulations and guidelines, Veeva platform, Microsoft Project Server, reporting tools and report development, and regulatory strategy experience.