Submissions & Regulatory Intelligence Manager (Clinical Data Standards)

Location: Hybrid, with the role available in Belgium, the Netherlands, the United Kingdom, Switzerland, or the United States; 3 days onsite per week preferred for US locations.

Base pay: Belgium €79,800–€137,770; Netherlands €68,600–€119,600; Switzerland CHF117,000–CHF202,170; United States $117,000–$201,250.

Company

Johnson & Johnson develops healthcare solutions through Innovative Medicine and MedTech, with a focus on treatments, clinical research, and patient health.

What you will do

• Provide expert guidance on clinical study data regulatory submission requirements and strategies.
• Interpret new and updated regulatory health authority and industry guidance for internal stakeholders.
• Act as the point of contact for data management, clinical and statistical programming, and global regulatory affairs teams on submission deliverables.
• Maintain expertise in regulatory validation and compliance rules for SDTM and ADaM submission packages.
• Support tools, systems, checklists, and templates used to verify data package compliance.
• Lead or support the Submission Center of Excellence, including workload distribution and post-database-lock submission readiness.

Requirements

• Bachelor’s degree in a scientific, technology, or healthcare discipline, or equivalent experience; advanced degrees are preferred.
• At least 6 years of relevant pharmaceutical or scientific experience in data management, biostatistics, clinical programming, or statistical programming.
• Expert knowledge of GCP, ICH, SDTM, ADaM, and related regulatory requirements and industry standards.
• Experience with regulatory submissions such as NDA or BLA is an asset.
• Strong written and verbal communication, interpersonal, customer focus, leadership, decision-making, and problem-solving skills.
• Excellent spoken and written English required.

Culture & Benefits

• Flexible working environment supporting work-life balance.
• Career development opportunities.
• Annual bonus or sales commissions depending on pay grade and location.
• Vacation, parental, bereavement, caregiver, and volunteer leave.
• Well-being reimbursement and programs supporting financial, physical, and mental health.
• Insurance plans, service anniversary awards, and recognition awards subject to plan terms.