Submissions & Regulatory Intelligence Manager (Hybrid)

Johnson & Johnson Innovative Medicine; Allschwil; Hybrid; CHF 117,000 - 202,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Well-being reimbursement

Career development opportunities

Job summary

Johnson & Johnson Innovative Medicine is seeking a Submissions & Regulatory Intelligence Manager to lead clinical data standards initiatives within IDAR, collaborating with data management, statistics, regulatory affairs and study teams to ensure compliant, timely submissions.

The role spans guidance interpretation, SDTM/ADaM work, and cross-border posting, with hybrid work options across locations including Allschwil. Strong English communication and leadership are essential.

Qualifications

• Bachelor’s degree in a scientific, technology or healthcare discipline, or equivalent experience.
• At least 6 years of relevant pharmaceutical/scientific experience.
• Expert knowledge of regulatory requirements (GCP, ICH) and 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.
• Excellent spoken and written English.

Responsibilities

• Act as the single Point of Contact for data management, clinical and statistical programming, and global regulatory affairs for data submission deliverables.
• Provide interpretation of newly released or updated Regulatory Health Authority guidance and IDAR submission requirements.
• Support ownership by SRI of tools, templates and checklists that facilitate data package compliance checking for IDAR.
• Lead submission readiness post-DBL for SDTM/ADaM and documentation.
• Serve as lead for SubCOE support and cross-functional workload distribution.

Skills

Advanced Analytics

Clinical Data Management

Clinical Trials Operations

Data Privacy Standards

Data Savvy

Good Clinical Practice

Innovation

Process Improvements

Regulatory Affairs Management

Research Ethics

Education

Bachelor’s degree in a scientific field

Advanced degree preferred (Master/PhD)

Job description

Johnson & Johnson Innovative Medicine is seeking a Submissions & Regulatory Intelligence Manager to lead clinical data standards initiatives within IDAR, collaborating with data management, statistics, regulatory affairs and study teams to ensure compliant, timely submissions.

The role spans guidance interpretation, SDTM/ADaM work, and cross-border posting, with hybrid work options across locations including Allschwil. Strong English communication and leadership are essential.