Sr. Regulatory Affairs Professional, Global TA

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

Role: Senior Regulatory Affairs Professional supporting global R&D initiatives within Johnson & Johnson's Innovative Medicine division, focusing on diverse drug development programs and marketed products.

Responsibilities

• participating in global/regional regulatory teams
• advising on regulatory strategies
• preparing agency meetings
• managing communication with health authorities
• reviewing clinical trial and submission documents
• ensuring compliance with regulatory requirements

The role involves understanding regional regulatory environments, supporting inspections/audits, and contributing to lifecycle management.

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, with knowledge of drug development processes.

Preferred

• Experience in regulated industries
• regulatory submission expertise in US/EMA guidelines
• cross-therapeutic experience
• health authority interactions
• project management skills

Skills

• Strong communication
• analytical reasoning
• strategic thinking
• regulatory compliance

High-Value specifics include supporting early to late-stage development and lifecycle activities across multiple therapeutic areas in a fast-paced, innovative environment.

Location options are Spring House, PA, Raritan, NJ, or Titusville, NJ, with a focus on cross-functional collaboration and regulatory submission management.