Senior Principal Scientist, CMC Reg Affairs Combo Products

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

Benefits offered by this job

Vacation –120 hours per calendar year

Sick time – 40 hours per calendar year

Holiday pay –13 days per calendar year

Parental Leave – 480 hours within one

Bereavement Leave – 240 hours

Volunteer Leave – 32 hours per year

Military Spouse Time-Off – 80 hours

Job summary

Johnson & Johnson Innovative Medicine is seeking a Senior Principal Scientist, CMC Regulatory Affairs - Combination Products. This hybrid role can be located in Raritan, NJ; Titusville, NJ; Spring House, PA; or Horsham, PA.

You will lead complex regulatory strategies for drug-device combinations, mentor cross-functional teams, and influence regulatory decisions globally across multiple programs.

Qualifications

• Minimum 10 years of experience in Regulatory Affairs, Quality, and/or Product Development.
• Experience with global regulatory submissions and Health Authority interactions.
• Knowledge of global regulatory requirements for drug-device combination products and medical devices (FDA, EU MDR).

Responsibilities

• Lead global regulatory strategies for complex, drug-device combination products.
• Provide strategic oversight of device/combination product submission content and regulatory documentation.
• Represent Johnson & Johnson Innovative Medicine in external regulatory activities and industry forums.
• Mentor and coach regulatory and cross-functional colleagues to build capability.
• Support lifecycle management and regulatory strategy for combination products across programs.

Skills

Communication

Negotiation

Strategic thinking

Mentoring

Education

Bachelor’s degree in a scientific/engineering/pharma field

Advanced degree (Masters/PhD) preferred

Job description

Johnson & Johnson Innovative Medicine is seeking a Senior Principal Scientist, CMC Regulatory Affairs - Combination Products. This hybrid role can be located in Raritan, NJ; Titusville, NJ; Spring House, PA; or Horsham, PA.

You will lead complex regulatory strategies for drug-device combinations, mentor cross-functional teams, and influence regulatory decisions globally across multiple programs.