Submissions & Reg. Intelligence Mgr.

Johnson & Johnson seeks a Submissions & Regulatory Intelligence Manager in Allschwil, Switzerland to lead clinical data standards strategy and regulatory compliance efforts. The role provides expert guidance on submission requirements, manages data standards programs, and serves as a key point of contact across clinical, statistical, and regulatory teams.

Responsibilities

• Provide expert guidance on regulatory submission requirements and industry standards documentation
• Serve as point of contact for data management, statistical programming, and regulatory affairs teams on submission deliverables
• Maintain and develop deep expertise in current regulatory health authority guidance and compliance rules
• Lead submission readiness activities post-database lock to ensure SDTM, ADaM, and documentation compliance
• Coach and train junior colleagues on clinical data standards application and regulatory requirements

Requirements

• Bachelor's degree in scientific, technology, or healthcare discipline; advanced degree preferred
• Minimum 6 years pharmaceutical or scientific experience in data management, biostatistics, or clinical roles
• Deep expertise in regulatory health authority guidance and data submission compliance requirements
• Knowledge of SDTM/ADaM submission packages and regulatory validation rules
• Demonstrated ability to develop and implement clinical data standards strategies
• Strong communication skills across multiple internal and external stakeholder groups