Submissions & Regulatory Intelligence Lead

6084-Janssen Research & Development, LLC Legal Entity; Spring House (PA); On-site; USD 117,000 - 201,000; Full time

Benefits offered by this job

Health insurance

Performance bonus

401(k) retirement plan

Job summary

Johnson & Johnson is seeking a Submissions & Regulatory Intelligence Manager within IDAR to provide expert guidance on clinical data submission requirements and regulatory strategies across multiple countries.

You will serve as the primary point of contact for data management, statistical programming, and global regulatory affairs, ensuring SDTM/ADaM readiness and compliance with RHA guidance.

Qualifications

• A Bachelor’s degree in a scientific, technology or healthcare discipline, or equivalent experience.
• Advanced degrees preferred (e.g., Master, PhD)
• At least 6 years of relevant pharmaceutical/scientific experience in a related discipline; e.g., data management, biostatistics, clinical or statistical programming!
• Expert knowledge of relevant regulatory requirements (e.g., GCP, ICH) and industry standards (e.g., 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
• Demonstrated leadership in decision making and problem solving
• Excellent spoken and written English

Responsibilities

• Act as a top-level specialist to establish programs and innovative strategies for Clinical Data Standards.
• Coach and train junior colleagues in clinical data standards application.
• Integrate Credo and Leadership Imperatives into team goals and decisions.
• Provide expert guidance on data submission requirements and regulatory strategies across multiple countries.

Skills

Advanced Analytics

Clinical Data Management

Clinical Trials Operations

Data Privacy Standards

Data Savvy

Good Clinical Practice (GCP)

Innovation

Leverages Information

Process Improvements

Regulatory Affairs Management

Research Ethics

Technical Credibility

Education

Bachelor’s degree in a scientific, technology or healthcare discipline

Advanced degrees preferred (e.g., Master, PhD)

Job description

Johnson & Johnson is seeking a Submissions & Regulatory Intelligence Manager within IDAR to provide expert guidance on clinical data submission requirements and regulatory strategies across multiple countries.

You will serve as the primary point of contact for data management, statistical programming, and global regulatory affairs, ensuring SDTM/ADaM readiness and compliance with RHA guidance.