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, monitors quality and drives process improvement, and acts as the main project management contact for regulatory plans. It is based in Allschwil, Switzerland, 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.
• Translate global regulatory strategy into executable plans, manage health authority meeting planning, worldwide submissions and global filing and launch strategies, and consolidate regulatory strategy and pre- and post-submission activities.
• Produce detailed plans, risk and opportunity playbooks and scenario evaluations, and support rapid, informed decisions.
• Support the Global Regulatory Team, including meetings with the Submission Working Group and Rapid Response Team, and share regulatory information with partners.
• Lead the execution of marketing applications, clinical variations and pediatric submissions, defining roles and mitigating risks.
• Drive process improvements, build regulatory budgets in Planisware and support resource and cost planning across the R&D portfolio.

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.