CMC Regulatory Lead, Synthetics & New Modalities

Scorpion Therapeutics; New Jersey; Hybrid; USD 120,000 - 180,000; Full time

Job summary

Johnson & Johnson Innovative Medicine is seeking a Senior Scientist, Product Lead in CMC Regulatory Affairs for Synthetics and New Modalities. You will steer global regulatory strategies and contribute to regulatory dossiers across development and commercialization stages.

The role involves leading submissions, collaborating with global teams, and ensuring compliance with health authority expectations, with a hybrid work setup across NJ/PA locations.

Qualifications

• Bachelor's degree in Biological, Pharmaceutical, Chemical, or Engineering Sciences required.
• 4+ years in pharmaceutical or healthcare industry desired.
• Experience in drug development, analytical development, or manufacturing preferred.
• Knowledge of global health authority regulations and strong communication skills are essential.

Responsibilities

• Develop and execute global CMC regulatory strategies.
• Contribute to regulatory dossier preparations.
• Support filings for development and marketed products.
• Collaborate on global regulatory and cross-functional teams.
• Provide regulatory expertise on CMC topics.
• Lead regulatory submissions.
• Manage country-specific documentation.
• Support health authority inspections.
• Drive continuous improvement and ensure regulatory compliance with global strategies and therapeutic area needs.

Skills

Regulatory strategy

Regulatory communications

Defend regulatory strategies

Education

Bachelor's degree in Biological, Pharmaceutical, Chemical, or Engineering Sciences

Job description

Johnson & Johnson Innovative Medicine is seeking a Senior Scientist, Product Lead in CMC Regulatory Affairs for Synthetics and New Modalities. You will steer global regulatory strategies and contribute to regulatory dossiers across development and commercialization stages.

The role involves leading submissions, collaborating with global teams, and ensuring compliance with health authority expectations, with a hybrid work setup across NJ/PA locations.