Regulatory Submissions & Data Standards Lead

Johnson And Johnson; High Wycombe; Hybrid; GBP 90,000 - 120,000; Full time

Benefits offered by this job

Flexible working environment

Career development opportunities

Competitive salary and benefits

Job summary

Johnson & Johnson in the United Kingdom seeks a Submissions & Regulatory Intelligence Manager to lead clinical data submission strategies within IDAR. You will collaborate across data management, statistics, and regulatory affairs to ensure SDTM/ADaM readiness and regulatory compliance for NDA/BLA programs.

Candidates bring 6+ years in pharma data roles, strong GCP/ICH knowledge, and proven leadership. This hybrid role offers a structured path for professional growth and global collaboration.

Qualifications

• Bachelor’s degree in scientific, technology or healthcare discipline; advanced degrees preferred.
• 6+ years in pharmaceutical/scientific roles such as data management or biostatistics.
• Expert knowledge of regulatory requirements (GCP, ICH) and industry standards (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 expert guidance on data submission requirements and strategies.
• Coordinate with data management, statistics, regulatory affairs for IDAR submissions.
• Lead on data standards programs and tool development.
• Coach junior staff and ensure regulatory compliance.

Skills

Advanced Analytics

Clinical Data Management

Clinical Trials Operations

Data Privacy Standards

Data Savvy

GCP

Regulatory Affairs Management

Research Ethics

Innovation

Technical Credibility

Education

Bachelor’s degree in scientific, technology or healthcare discipline

Advanced degrees preferred (Master/PhD)

Job description

Johnson & Johnson in the United Kingdom seeks a Submissions & Regulatory Intelligence Manager to lead clinical data submission strategies within IDAR. You will collaborate across data management, statistics, and regulatory affairs to ensure SDTM/ADaM readiness and regulatory compliance for NDA/BLA programs.

Candidates bring 6+ years in pharma data roles, strong GCP/ICH knowledge, and proven leadership. This hybrid role offers a structured path for professional growth and global collaboration.