Senior Scientist, CMC Regulatory—Combination Products

Johnson & Johnson Co.; Horsham (PA); Hybrid; USD 137,000 - 236,000; Full time

Benefits offered by this job

Vacation 120 hours/year

Sick time

Holiday pay

Parental Leave

Volunteer Leave

Job summary

Johnson & Johnson Innovative Medicine seeks a Senior Principal Scientist, CMC Regulatory Affairs - Combination Products to lead regulatory strategies for high‑risk drug‑device programs. Hybrid role across Raritan, Titusville, Spring House, or Horsham locations.

You will provide expert interpretation of global requirements, mentor teams, and drive submissions for complex combination products, aligning with Health Authority expectations and lifecycle management goals.

Qualifications

• Minimum 10 years of Regulatory Affairs, Quality, and/or Product Development experience.
• Experience in pharmaceutical, biotechnology, medical device, or drug-device areas.
• Understanding of drug-device combination product development and design controls.
• Knowledge of global regulatory requirements (FDA Part 4, EU MDR, QMSR, etc.).
• Experience supporting global regulatory submissions and Health Authority interactions.

Responsibilities

• Lead complex regulatory strategies for clinical, marketing, and lifecycle submissions.
• Provide strategic oversight of device and combination product submissions.
• Lead regulatory assessments for manufacturing, device changes, and post-approval activities.
• Represent and mentor regulatory and cross-functional teams across a global matrix.
• Engage with external authorities and industry groups to inform regulatory positions.
• Drive regulatory process improvements and capability development.

Skills

Regulatory strategy

Cross-functional leadership

Regulatory affairs

Global submissions

Project leadership

Education

Bachelor’s degree or equivalent

Advanced degree preferred

Job description

Johnson & Johnson Innovative Medicine seeks a Senior Principal Scientist, CMC Regulatory Affairs - Combination Products to lead regulatory strategies for high‑risk drug‑device programs. Hybrid role across Raritan, Titusville, Spring House, or Horsham locations.

You will provide expert interpretation of global requirements, mentor teams, and drive submissions for complex combination products, aligning with Health Authority expectations and lifecycle management goals.