Submissions & Regulatory Intelligence Leader

Johnson & Johnson Innovative Medicine; Beerse; Hybrid; EUR 80,000 - 138,000; Full time

Benefits offered by this job

Flexible working environment

Annual bonus

Career development opportunities

Job summary

Johnson & Johnson Innovative Medicine is seeking a Submissions & Regulatory Intelligence Manager to lead the Clinical Data Standards program within IDAR. You will guide regulatory submission strategies, SDTM/ADaM implementations, and ensure consistent data standards across trials and partners.

The role involves coordinating with global teams across Beerse, Leiden, Maidenhead, and Spring House, with hybrid onsite work and frequent collaboration for submissions readiness and regulatory compliance.

Qualifications

• Bachelor’s degree in a scientific, technology or healthcare discipline; advanced degrees preferred.
• 6+ years of pharma/science experience in data management, biostatistics, or programming.
• Expert knowledge of regulatory requirements (GCP, ICH) and SDTM/ADaM.

Responsibilities

• Lead IDAR data submission standards and ensure regulatory compliance.
• Coordinate with study teams, data management, and regulatory affairs for submissions.
• Mentor junior colleagues in clinical data standards applications and processes.
• Serve as point of contact for data delivery requirements across teams.

Skills

Regulatory knowledge

GCP knowledge

Leadership

Communication skills

Cross-functional collaboration

English proficiency

Data submission oversight

Education

Bachelor's degree in science/healthcare

Tools

SDTM

ADaM

Regulatory submissions tools

Job description

Johnson & Johnson Innovative Medicine is seeking a Submissions & Regulatory Intelligence Manager to lead the Clinical Data Standards program within IDAR. You will guide regulatory submission strategies, SDTM/ADaM implementations, and ensure consistent data standards across trials and partners.

The role involves coordinating with global teams across Beerse, Leiden, Maidenhead, and Spring House, with hybrid onsite work and frequent collaboration for submissions readiness and regulatory compliance.