Regulatory Submissions & Data Standards Lead

7555-Janssen Pharmaceutica NV Legal Entity; Geel; Hybrid; EUR 83,000 - 138,000; Full time

Benefits offered by this job

Flexible working environment

Career development opportunities

Competitive salary and benefits

Job summary

Johnson & Johnson is seeking a Submissions & Regulatory Intelligence Manager within Integrated Data Analytics & Reporting (IDAR) to lead clinical data standards initiatives and support regulatory submissions across multiple countries. You will collaborate with data management, biostatistics, programming, and regulatory affairs teams to ensure compliant, timely submission deliverables.

The role emphasizes leadership, deep regulatory knowledge (GCP/ICH, SDTM/ADaM), and the ability to coordinate

Qualifications

• A Bachelor's degree in a scientific, technology or healthcare discipline, or equivalent experience.
• Advanced degrees preferred (e.g., Master, PhD).
• At least 6 years of relevant pharmaceutical/scientific experience in a related discipline; e.g., data management, biostatistics, clinical or statistical programming.
• Expert knowledge of regulatory requirements (e.g., GCP, ICH) and industry standards (e.g., SDTM, ADaM).
• Experience with regulatory submissions (NDA, BLA) is an asset.
• Demonstrated written and verbal communications skills.
• Demonstrated customer focus and solution-oriented experience.
• Demonstrated interpersonal skills to build relationships with internal and external business partners.
• Demonstrated leadership on cross-functional projects.
• Demonstrated leadership in decision making and problem solving.
• Excellent spoken and written English.

Responsibilities

• Provide expertise to the IDAR department in regulatory submission requirements and strategies.
• Serve as single point of contact for data management, clinical and statistical programming, and global regulatory affairs for deliverables.
• Maintain deep expertise in current RHA guidance and SDTM/ADaM rules for data submission packages.
• Lead the Submission Center of Excellence as POC for study teams and oversee workload distribution.

Skills

Advanced Analytics

Clinical Data Management

Clinical Trials Operations

Data Privacy Standards

Data Savvy

Good Clinical Practice (GCP)

Innovation

Leverages Information

Process Improvements

Regulatory Affairs Management

Research Ethics

Technical Credibility

Education

Bachelor's degree in a scientific, technology or healthcare discipline

Advanced degrees preferred (Master, PhD)

Job description

Johnson & Johnson is seeking a Submissions & Regulatory Intelligence Manager within Integrated Data Analytics & Reporting (IDAR) to lead clinical data standards initiatives and support regulatory submissions across multiple countries. You will collaborate with data management, biostatistics, programming, and regulatory affairs teams to ensure compliant, timely submission deliverables.

The role emphasizes leadership, deep regulatory knowledge (GCP/ICH, SDTM/ADaM), and the ability to coordinate