Submissions & Regulatory Intelligence Lead - Hybrid

Johnson & Johnson Innovative Medicine

High Wycombe

Hybrid

GBP 70,000 - 110,000

Full time

14 days+

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Benefits offered by this job

Flexible working environment

Career development opportunities

Extensive benefits package

Job summary

Johnson & Johnson Innovative Medicine is seeking a Submissions & Regulatory Intelligence Manager to lead regulatory submission strategies across IDAR. You will collaborate with data management, statistics, and regulatory affairs teams to ensure compliant, timely deliverables for trial data and submissions.

The role requires deep knowledge of GCP/ICH, SDTM/ADaM standards, and strong cross-functional leadership. Hybrid work and international collaborations are supported across multiple sites.

Qualifications

Bachelor's degree in science or healthcare; advanced degrees preferred.
At least 6 years of pharmaceutical/scientific experience in data management, biostatistics, or statistics programming.
Expert knowledge of regulatory requirements (GCP, ICH) and SDTM/ADaM standards.

Responsibilities

Provide expertise on regulatory submission requirements and strategies for clinical data.
Serve as single point of contact for data management, biostatistics programming, and regulatory affairs.
Lead cross-functional projects and support the Submission Center of Excellence.

Skills

Regulatory knowledge

Leadership

Communication skills

English proficiency

Cross-functional collaboration

Education

Bachelor's degree in science/healthcare

Tools

SDTM/ADaM standards

Job description

The role requires deep knowledge of GCP/ICH, SDTM/ADaM standards, and strong cross-functional leadership. Hybrid work and international collaborations are supported across multiple sites.

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