Sr. Principal Scientist, CMC Reg – Combo Products

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

Job summary

Johnson & Johnson Innovative Medicine is hiring a Senior Principal Scientist, CMC Regulatory Affairs – Combination Products, to lead complex regulatory strategies across drug-device combinations. You will guide cross-functional teams through global submissions, regulatory filings, and lifecycle management while ensuring compliance with evolving requirements.

This hybrid role can be located in Raritan, NJ; Titusville, NJ; Spring House, PA; or Horsham, PA, and involves collaboration with

Qualifications

• Minimum 10 years of relevant experience in Regulatory Affairs, Quality, and/or Product Development.
• Experience with drug-device combination products and global regulatory submissions.
• Ability to lead complex regulatory strategies and guide cross-functional teams.

Responsibilities

• Lead development of regulatory strategies for complex combination products and device constituents.
• Provide expert interpretation of global regulatory requirements and evolving expectations.
• Mentor regulatory and cross-functional colleagues and drive organizational capability.
• Represent Johnson & Johnson in external regulatory and industry forums.
• Coordinate cross-functional activities across regulatory, quality, and product development teams.

Skills

Regulatory affairs

Regulatory strategy

Cross-functional leadership

Quality systems

Regulatory submissions

Communication

Project management

Education

Bachelor’s degree

Advanced degree preferred

Job description

Johnson & Johnson Innovative Medicine is hiring a Senior Principal Scientist, CMC Regulatory Affairs – Combination Products, to lead complex regulatory strategies across drug-device combinations. You will guide cross-functional teams through global submissions, regulatory filings, and lifecycle management while ensuring compliance with evolving requirements.

This hybrid role can be located in Raritan, NJ; Titusville, NJ; Spring House, PA; or Horsham, PA, and involves collaboration with