CMC Regulatory Scientist - Combination Products

Johnson & Johnson Co.; Raritan (NJ); On-site; USD 168,000 - 291,000; Full time

Benefits offered by this job

Vacation – 120 hours per year

Parental Leave – 480 hours per year

Job summary

Johnson & Johnson is seeking a Distinguished Scientist, CMC Regulatory Affairs – Combination Products to lead regulatory strategy for novel drug-device programs across multiple sites in the United States. The role requires deep expertise in CMC, global submissions, and cross-functional program leadership.

You will partner with regulatory intelligence, policy, and senior stakeholders to ensure compliant strategies and timely submissions while mentoring teams and shaping external policy

Qualifications

• Bachelor’s degree in a scientific discipline required.
• Minimum 12 years of relevant experience in pharma/biotech/medical device or regulated healthcare.
• Demonstrated expertise in drug-device combination product regulatory strategy and submissions.

Responsibilities

• Lead strategic CMC regulatory strategies for novel, complex combination products and device-related programs.
• Provide regulatory guidance to cross-functional teams and external partners.
• Mentor and influence senior stakeholders; translate external developments into RA strategies.

Skills

Regulatory Affairs Management

Regulatory Compliance

Technical Writing

Strategic Thinking

Stakeholder Management

Cross-functional Collaboration

Education

Bachelor’s degree in biological/pharmaceutical/chemical/engineering/regulatory science/medical device

Job description

Johnson & Johnson is seeking a Distinguished Scientist, CMC Regulatory Affairs – Combination Products to lead regulatory strategy for novel drug-device programs across multiple sites in the United States. The role requires deep expertise in CMC, global submissions, and cross-functional program leadership.

You will partner with regulatory intelligence, policy, and senior stakeholders to ensure compliant strategies and timely submissions while mentoring teams and shaping external policy