Senior Principal Scientist, CMC Regulatory - Combo Products

Biopharma Careers; Raritan (NJ); Hybrid; USD 137,000 - 236,000; Full time

Benefits offered by this job

401(k) plan

Pension plan

Long-term incentive program

Job summary

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

You will lead the regulatory strategies for high-risk combination products and coordinate global submissions, with mentoring across teams. Responsibilities include shaping regulatory pathways, managing Health Authority interactions, and ensuring lifecycle management success.

Qualifications

• Minimum of 10 years of relevant experience in Regulatory Affairs, Quality, and/or Product Development.
• Experience in pharmaceutical, biotechnology, medical device, or combination product environments.
• Understanding of drug-device combination product development processes and related regulatory requirements.
• Knowledge of global regulatory requirements for drug-device combination products and medical devices.

Responsibilities

• Lead complex regulatory strategies for clinical, marketing, and lifecycle submissions involving combination products.
• Provide strategic oversight of device and combination product submission content for clinical trials, marketing applications, and Notified Body dossiers.
• Lead regulatory assessments for changes with potential global impact across multiple programs and therapeutic areas.
• Represent the organization in external regulatory activities and contribute to industry regulatory policy discussions.
• Mentor and coach regulatory and cross-functional colleagues to build organizational capability.

Skills

Regulatory Affairs

Quality Management

Leadership

Written & Verbal Communication

Regulatory Strategy

Cross-functional Collaboration

Education

Bachelor’s degree

Advanced degree preferred

Job description

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

You will lead the regulatory strategies for high-risk combination products and coordinate global submissions, with mentoring across teams. Responsibilities include shaping regulatory pathways, managing Health Authority interactions, and ensuring lifecycle management success.