Senior Scientist, Product Lead CMC Regulatory Affairs

Role: Senior Scientist, Product Lead in CMC Regulatory Affairs for Synthetics and New Modalities at Johnson & Johnson's Innovative Medicine division. Responsibilities: develop and execute global CMC regulatory strategies, contribute to regulatory dossier preparations, support filings for development and marketed products, and collaborate on global regulatory and cross-functional teams. Provide regulatory expertise on CMC topics, lead regulatory submissions, manage country-specific documentation, and support health authority inspections. Drive continuous improvement and ensure regulatory compliance aligned with global strategies and therapeutic area needs. Qualifications: Bachelor's in Biological, Pharmaceutical, Chemical, or Engineering Sciences; 4+ years in pharmaceutical or healthcare industry, with experience in drug development, analytical development, or manufacturing. Knowledge of global health authority regulations, strong communication skills, and ability to defend regulatory strategies. Preferred: advanced degrees (Master’s, PharmD, Ph.D.) and experience working with health authorities independently. High-Value: Focus on small molecules or biologics in development stages, supporting global filings, with emphasis on regulatory strategy for innovative modalities. Work setup: hybrid, based in Titusville, NJ; Raritan, NJ; Spring House, PA; or Horsham, PA.