Sr Scientist Product Lead CMC RA

Role: Senior Scientist Product Lead in CMC Regulatory Affairs specializing in Synthetics and New Modalities, supporting global regulatory strategies and dossier development for innovative medicines. Responsibilities: develop and implement CMC regulatory plans for development and marketed products, serve as the Regulatory CMC Lead on cross-functional teams, prepare and coordinate regulatory dossiers for global submissions, and support health authority interactions and inspections. Ensure compliance with global regulations and drive continuous improvement. Qualifications: BS in biological, pharmaceutical, chemical, or engineering sciences with 6+ years of industry experience; MS, Ph.D., or Pharm.D. preferred. Skills: strong understanding of biology, chemistry, and engineering relevant to pharma; experience in drug development, analytical development, or manufacturing; excellent communication and cross-functional collaboration skills. High-Value: focus on innovative medicines, including biologics or new modalities, with responsibilities spanning development through lifecycle management, supporting global filings and regulatory strategies. Work setup: multiple US locations (Pennsylvania, New Jersey), with potential for international postings in Belgium or Poland.