Hybrid CMC Regulatory Lead - Synthetics & New Modalities

Johnson & Johnson Innovative Medicine; Raritan (NJ); Hybrid; USD 109,000 - 175,000; Full time

Job summary

Johnson & Johnson's Innovative Medicine R&D seeks a Senior Scientist, Product Lead CMC Regulatory Affairs for Synthetics and New Modalities to develop and implement global CMC regulatory strategies for development and marketed biopharmaceuticals, with a focus on synthetic and novel modalities.

The role supports regulatory submissions, compliance, lifecycle management, and interacts with health authorities, while collaborating across regulatory and CMC teams in a hybrid setup across multiple U.S.

Qualifications

• Bachelor's degree in biological, chemical, pharmaceutical, or engineering science.
• At least 4 years of relevant industry experience in drug development, analytical development, or manufacturing.
• Knowledge of global regulatory laws and experience interacting with health authorities.
• Preferred advanced degrees (Master's, PharmD, Ph.D.), extensive experience with biologics or advanced modalities.

Responsibilities

• Integrate disease biology, pharmacology, and clinical data to inform regulatory strategy.
• Prepare regulatory dossiers and support global filings.
• Represent CMC in cross-functional teams including CMC and Regulatory Teams.
• Perform regulatory submissions, ensure compliance, and support lifecycle management.

Job description

Johnson & Johnson's Innovative Medicine R&D seeks a Senior Scientist, Product Lead CMC Regulatory Affairs for Synthetics and New Modalities to develop and implement global CMC regulatory strategies for development and marketed biopharmaceuticals, with a focus on synthetic and novel modalities.

The role supports regulatory submissions, compliance, lifecycle management, and interacts with health authorities, while collaborating across regulatory and CMC teams in a hybrid setup across multiple U.S.