Regulatory Submissions & Intelligence Lead

8542-Actelion Pharmaceuticals Ltd Legal Entity; Allschwil; Hybrid; CHF 117,000 - 202,000; Full time

Benefits offered by this job

Competitive salary

Flexible working environment

Career development opportunities

Job summary

Johnson & Johnson is seeking a Submissions & Reg Intelligence Manager within Integrated Data Analytics & Reporting (IDAR) to advance the Clinical Data Standards organization and ensure regulatory submission readiness. The role acts as a SME and leader across data standards, collaborating with study teams and regulatory affairs.

The position emphasizes coaching, process improvements, and strong English communication, with a hybrid work model in Allschwil and surrounding areas.

Qualifications

• Bachelor’s degree in a scientific, technology or healthcare discipline is required.
• Advanced degrees (Master, PhD) are preferred.
• Experience in pharmaceutical data management or regulatory submissions is expected.

Responsibilities

• Provide expertise on clinical study data regulatory submission requirements.
• Serve as single point of contact for data management and regulatory teams.
• Ensure SDTM/ADaM readiness and regulatory compliance.

Skills

Leadership

Cross-functional teamwork

Written and verbal communication

English proficiency

Regulatory affairs knowledge

Stakeholder management

Problem solving

Education

Bachelor’s degree in scientific, technology or healthcare discipline

Advanced degrees preferred (Master, PhD)

Tools

Regulatory submissions tools

Job description

Johnson & Johnson is seeking a Submissions & Reg Intelligence Manager within Integrated Data Analytics & Reporting (IDAR) to advance the Clinical Data Standards organization and ensure regulatory submission readiness. The role acts as a SME and leader across data standards, collaborating with study teams and regulatory affairs.

The position emphasizes coaching, process improvements, and strong English communication, with a hybrid work model in Allschwil and surrounding areas.