Regulatory Submissions Intelligence Lead

Johnson & Johnson Innovative Medicine; Hopewell Township (NJ); Hybrid; USD 117,000 - 201,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) retirement plan

Paid time off

Job summary

Johnson & Johnson Innovative Medicine seeks a Submissions & Regulatory Intelligence Manager within Integrated Data Analytics & Reporting (IDAR) to lead clinical data standards programs and ensure regulatory submission readiness across SDTM/ADaM.

The role requires a bachelor’s degree, 6+ years in pharmaceutical data management or regulatory affairs, deep knowledge of GCP/ICH, and strong English communication.

Qualifications

• Bachelor’s degree in a scientific, technology or healthcare discipline.
• At least 6 years of pharmaceutical/scientific experience.
• Expert knowledge of regulatory requirements (GCP, ICH) and industry standards (SDTM, ADaM).
• Excellent written and verbal English; strong communication skills.
• Experience with regulatory submissions (NDA, BLA) is an asset.

Responsibilities

• Act as a top-level specialist to establish programs and strategies for Clinical Data Standards.
• Manage standards, projects, or processes for Clinical Data Standards in line with internal strategy and regulatory requirements.
• Support SDTM/ADaM submission readiness and data package compliance.
• Lead or support SubCOE activities and coach junior colleagues.
• Coordinate with internal and external partners to ensure regulatory submission deliverables.

Skills

Regulatory knowledge

Clinical data management

Communication skills

English proficiency

Education

Bachelor’s degree in science/healthcare

Job description

Johnson & Johnson Innovative Medicine seeks a Submissions & Regulatory Intelligence Manager within Integrated Data Analytics & Reporting (IDAR) to lead clinical data standards programs and ensure regulatory submission readiness across SDTM/ADaM.

The role requires a bachelor’s degree, 6+ years in pharmaceutical data management or regulatory affairs, deep knowledge of GCP/ICH, and strong English communication.