Sr. Regulatory Affairs Professional, Global TA

Scorpion Therapeutics; Spring House (PA); On-site; USD 140,000 - 190,000; Full time

Job summary

Johnson & Johnson's Innovative Medicine division is seeking a Senior Regulatory Affairs Professional to shape regulatory strategies and lead global submissions across multiple programs. You will partner with cross-functional teams to ensure compliant development and lifecycle management in a dynamic environment.

The role emphasizes strong communication with health authorities, rigorous document review, and proactive collaboration to drive timely approvals in a complex, fast-paced setting.

Qualifications

• Bachelor’s degree in a scientific field with 6+ years of industry/academic experience, or advanced degrees with fewer years.
• Experience with US/EMA regulatory processes is preferred.
• Strong collaboration and communication across functions in a fast-paced environment.

Responsibilities

• Advise on global/regional regulatory strategies and prepare submissions across multiple therapeutic areas.
• Participate in regulatory team meetings and liaise with health authorities.
• Review clinical and regulatory documents and contribute to lifecycle management activities.
• Support interactions with health authorities and ensure compliance throughout drug development.

Skills

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

Project management

Interpersonal communication

Health authority liaison

Education

Bachelor’s degree in a scientific field

Job description

Senior Regulatory Affairs Professional

Global Therapeutic Area supporting Johnson & Johnson's Innovative Medicine division.

Primary objectives include advising on global/regional regulatory strategies, preparing submissions, and ensuring compliance across multiple therapeutic areas and product stages.

Responsibilities encompass participating in regulatory team meetings, liaising with health authorities, reviewing clinical and regulatory documents, and contributing to lifecycle management activities.

Qualifications require a bachelor’s in a scientific field plus 6+ years of industry or academic experience, or advanced degrees with fewer years.

Preferred skills include experience with US/EMA regulatory processes, responding to health authority requests, cross-functional collaboration, and diverse therapeutic area knowledge.

High-value details involve work on drug development programs from early to late stages, including marketed products, with emphasis on regulatory submission, approval processes, and compliance within a complex, fast-paced environment.

The role may involve interactions with health authorities and requires strong interpersonal, communication, and project management skills.

Work setup is in Raritan, NJ, Spring House, PA, or Titusville, NJ, with no specified travel requirements.