Regulatory Submissions Lead & Data Standards Expert

Johnson & Johnson Innovative Medicine; Leiden; Hybrid; EUR 69,000 - 120,000; Full time

Benefits offered by this job

Flexible working environment

Career development opportunities

Employee benefits

Job summary

Johnson & Johnson Innovative Medicine in the Netherlands seeks a Submissions & Regulatory Intelligence Manager within IDAR to advance clinical data standards and regulatory submission strategies across studies. You will work with study teams and partners to ensure SDTM/ADaM readiness and regulatory compliance.

You will lead cross-functional collaboration, translate complex guidance into actionable plans, and mentor junior staff while aligning with GCP and ICH requirements.

Qualifications

• Bachelor’s degree in a scientific, technology or healthcare discipline.
• 6+ years of pharmaceutical/scientific experience.
• Expert knowledge of regulatory requirements (GCP, ICH) and industry standards (SDTM, ADaM).
• Experience with regulatory submissions (NDA, BLA) is an asset.
• Excellent written and verbal English.

Responsibilities

• Provide expert guidance on data submission requirements and strategies.
• Serve as single Point of Contact for data management and regulatory affairs.
• Lead or support the Submission Center of Excellence initiatives.
• Coach junior colleagues in clinical data standards.

Skills

Advanced Analytics

Clinical Data Management

GCP

Regulatory Affairs

Data Privacy

Education

Bachelor's degree

Job description

Johnson & Johnson Innovative Medicine in the Netherlands seeks a Submissions & Regulatory Intelligence Manager within IDAR to advance clinical data standards and regulatory submission strategies across studies. You will work with study teams and partners to ensure SDTM/ADaM readiness and regulatory compliance.

You will lead cross-functional collaboration, translate complex guidance into actionable plans, and mentor junior staff while aligning with GCP and ICH requirements.