Principal Scientist, CMC Regulatory Affairs — Drug-Device

Johnson & Johnson Innovative Medicine; Spring House (PA); Hybrid; USD 117,000 - 201,000; Full time

Benefits offered by this job

Vacation 120 hours

Sick time 40 hours

Holiday pay

Long-term incentive program

Job summary

Johnson & Johnson Innovative Medicine is seeking a Principal Scientist, CMC Regulatory Affairs - Combination Products. Hybrid role across NJ/PA, location-flexible.

Lead regulatory strategies for drug-device combinations and support global submissions with cross-functional teams. Role requires 8+ years in regulatory affairs or related fields, strong written communication, and ability to influence across a global matrix organization.

Qualifications

• Bachelor’s degree or equivalent in scientific, engineering, pharmaceutical, regulatory science or related field.
• Advanced degree (Master’s, PharmD, Ph.D) preferred.
• 8+ years of relevant Regulatory Affairs, Quality, or Product Development experience.

Responsibilities

• Provide regulatory strategies for combination product programs and lifecycle activities.
• Collaborate cross-functionally with global teams and manage Health Authority interactions.
• Review submission content for device and combination product regulatory requirements.
• Assess regulatory impact of manufacturing, device, and product changes globally.
• Support regulatory guidance, process improvements, and team capability building.

Skills

Regulatory strategy

Cross-functional collaboration

Regulatory submissions

Written communication

Analytical thinking

Attention to detail

Travel willingness

Education

Bachelor’s degree

Advanced degree preferred

Job description

Johnson & Johnson Innovative Medicine is seeking a Principal Scientist, CMC Regulatory Affairs - Combination Products. Hybrid role across NJ/PA, location-flexible.

Lead regulatory strategies for drug-device combinations and support global submissions with cross-functional teams. Role requires 8+ years in regulatory affairs or related fields, strong written communication, and ability to influence across a global matrix organization.