Regulatory Submissions & Data Standards Lead

7360-Janssen-Cilag Limited Legal Entity; High Wycombe; Hybrid; GBP 90,000 - 130,000; Full time

Benefits offered by this job

Competitive salary and benefits

Flexible working environment

Job summary

Johnson & Johnson is seeking a Submissions & Regulatory Intelligence Manager to lead regulatory data submission strategies within IDAR. You will ensure SDTM/ADaM standards across trials and collaborate with data management, statistics, and regulatory teams.

The role requires deep regulatory knowledge, strong leadership, and excellent English communication to support global submissions and process improvements.

Qualifications

• 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 pharmaceutical/scientific experience in data management, biostatistics, or clinical programming.

Responsibilities

• Provide expert guidance on clinical data regulatory submission requirements and strategies.
• Lead cross-functional projects and ensure compliance with regulatory requirements.
• Serve as a main contact for data management, statistics, programming, and regulatory affairs teams.

Skills

Cross-functional leadership

Regulatory submissions

GCP/ICH knowledge

SDTM/ADaM

Data management

Clinical data standards

English communication

Education

Bachelor’s degree (science/healthcare)

Advanced degree preferred (Master/PhD)

Tools

SDTM tools

Regulatory submissions tools

Job description

Johnson & Johnson is seeking a Submissions & Regulatory Intelligence Manager to lead regulatory data submission strategies within IDAR. You will ensure SDTM/ADaM standards across trials and collaborate with data management, statistics, and regulatory teams.

The role requires deep regulatory knowledge, strong leadership, and excellent English communication to support global submissions and process improvements.