Global Regulatory Affairs Lead — Drug Development Lifecycle

Scorpion Therapeutics; Raritan (NJ); On-site; USD 130,000 - 185,000; Full time

Job summary

Johnson & Johnson's Innovative Medicine division seeks a Senior Regulatory Affairs Professional to support global R&D initiatives across diverse drug development programs and marketed products. You will participate in global/regional regulatory teams, advise on regulatory strategies, prepare agency meetings, and liaise with health authorities to ensure compliant submissions.

Location options include Spring House, PA or Raritan, NJ with hybrid cross-functional collaboration and lifecycle

Qualifications

• Bachelor's in a scientific discipline with 6+ years (or PharmD/PhD with 2+ years, or Master's with 3+ years) of relevant experience.
• Experience in drug development processes and global/regional regulatory environments.
• Strong knowledge of regulatory submission processes and health authority interactions.

Responsibilities

• Participate in global/regional regulatory teams and advise on strategies.
• Prepare agency meetings and manage communications with health authorities.
• Review clinical trial and submission documents for regulatory compliance.
• Support inspections/audits and lifecycle management across multiple programs.

Skills

Strong communication

Regulatory planning

Analytical reasoning

Cross-functional collaboration

Project management

Education

Bachelor's in scientific discipline

PharmD/PhD

Master's in life sciences

Job description

Johnson & Johnson's Innovative Medicine division seeks a Senior Regulatory Affairs Professional to support global R&D initiatives across diverse drug development programs and marketed products. You will participate in global/regional regulatory teams, advise on regulatory strategies, prepare agency meetings, and liaise with health authorities to ensure compliant submissions.

Location options include Spring House, PA or Raritan, NJ with hybrid cross-functional collaboration and lifecycle