Regulatory Submissions & Data Standards Lead

Johnson & Johnson Innovative Medicine

Breda

Hybrid

EUR 69,000 - 120,000

Full time

4 days ago

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Benefits offered by this job

Competitive salary & benefits

Flexible working environment

Career development opportunities

Job summary

Johnson & Johnson Innovative Medicine seeks a Submissions & Regulatory Intelligence Manager within Integrated Data Analytics & Reporting to guide data submission strategy and ensure regulatory compliance across trials. You will collaborate with study teams to align SDTM/ADaM standards and interpret regulatory guidance.

The role requires expertise in GCP/ICH, strong communication, and leadership across cross-functional projects, with hybrid work options across multiple locations.

Qualifications

Bachelor’s degree in scientific, technology or healthcare discipline.
Advanced degrees preferred (e.g., Master, PhD).
6+ years of pharmaceutical/scientific experience in a related discipline.

Responsibilities

Provide significant expertise to IDAR in clinical study data regulatory submission requirements and strategies.
Lead interpretation of regulatory guidance and submission information.
Support SDTM/ADaM submission readiness and data standards across trials.

Skills

Advanced Analytics

Clinical Data Management

Clinical Trials Operations

Data Privacy Standards

Data Savvy

Good Clinical Practice (GCP)

Innovation

Process Improvements

Regulatory Affairs Management

Research Ethics

Technical Credibility

Education

Bachelor’s degree in scientific/healthcare discipline

Advanced degrees preferred (Master/PhD)

Job description

The role requires expertise in GCP/ICH, strong communication, and leadership across cross-functional projects, with hybrid work options across multiple locations.

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