Submissions & Regulatory Intelligence Lead - Hybrid

Johnson & Johnson Innovative Medicine; High Wycombe; Híbrido; GBP 70.000 - 110.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Flexible working environment

Career development opportunities

Extensive benefits package

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Regulatory knowledge

Leadership

Communication skills

English proficiency

Cross-functional collaboration

Educación

Bachelor's degree in science/healthcare

Herramientas

SDTM/ADaM standards

Descripción del empleo

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.