Submissions & Regulatory Intelligence Manager

About the role

The Submissions & Regulatory Intelligence Manager will join Johnson & Johnson's Integrated Data Analytics & Reporting (IDAR) team to lead the Clinical Data Standards strategy. This role ensures consistency of clinical data standards across trials and compliance with regulatory requirements, acting as the primary point of contact for data submission deliverables.

Key responsibilities

• Provide expert guidance on regulatory submission requirements, including interpretation of new health authority guidance.
• Lead the Submission Center of Excellence, managing workload distribution and ensuring SDTM, ADaM, and documentation readiness post‑DBL.
• Develop and maintain tools, checklists, and templates that support data package compliance checking.
• Coach and train junior colleagues on clinical data standards application.

Required profile

• Bachelor’s degree in a scientific, technology or healthcare discipline; advanced degree preferred.
• At least 6 years of experience in pharmaceutical data management, biostatistics, clinical or statistical programming.
• Strong knowledge of regulatory requirements (GCP, ICH) and industry standards (SDTM, ADaM).
• Excellent written and verbal communication skills in English.

Required skills

• SDTM and ADaM submission packages.
• Regulatory submission processes (NDA, BLA).
• Regulatory Health Authority (RHA) guidance interpretation.
• GCP and ICH compliance.

What we offer

• Competitive salary with a range of 117,000‑202,170 CHF per year.
• Annual bonus based on individual and company performance.
• Flexible hybrid work model (3 days onsite per week preferred).
• Comprehensive health and well‑being benefits, parental leave, and career development opportunities.