Principal Scientist, CMC Regulatory (Drug-Device)

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

Benefits offered by this job

Vacation 120 hours per year

Sick time 40 hours per year

Holiday pay 13 days per year

Parental Leave 480 hours per year

Job summary

Johnson & Johnson Innovative Medicine is seeking a Principal Scientist, CMC Regulatory Affairs - Combination Products for a hybrid role located in Raritan, Titusville, Spring House, or Horsham. You will lead regulatory strategies for drug-device combination products, support submissions, health authority interactions, and lifecycle management globally.

The role requires 8+ years in Regulatory Affairs/QA/Development, strong cross-functional collaboration, and deep knowledge of global regulatory

Qualifications

• Minimum 8 years of relevant experience in Regulatory Affairs, Quality, and/or Product Development.
• Experience in pharmaceutical, biotechnology, medical device, or regulatory healthcare environments.
• Ability to develop and execute regulatory strategies for global programs and lifecycles.
• Strong written and verbal communication with cross-functional teams.
• Willingness to travel ~10% (domestic/international).

Responsibilities

• Provide regulatory expertise and interpretation of global CMC/NotifiedBody requirements for drug-device combination products.
• Develop and execute regulatory strategies for clinical, marketing, and lifecycle submissions.
• Review submission content for regulatory dossiers and health authority interactions.
• Provide regulatory assessments for changes and global impact.
• Collaborate with cross-functional teams and support regulatory process improvements.

Skills

Regulatory Strategy

Global Health Authority Interactions

Regulatory Submissions

Cross-Functional Collaboration

Drug-Device Regulations

Education

Bachelor's degree or equivalent in science/engineering/pharma

Advanced degree preferred (MS/PhD/PharmD)

Job description

Johnson & Johnson Innovative Medicine is seeking a Principal Scientist, CMC Regulatory Affairs - Combination Products for a hybrid role located in Raritan, Titusville, Spring House, or Horsham. You will lead regulatory strategies for drug-device combination products, support submissions, health authority interactions, and lifecycle management globally.

The role requires 8+ years in Regulatory Affairs/QA/Development, strong cross-functional collaboration, and deep knowledge of global regulatory