Sr Scientist Product Lead CMC RA

Role: Senior Scientist Product Lead CMC RA - Synthetics, New Modalities, focusing on regulatory chemistry, manufacturing, and controls (CMC) for innovative medicines. Responsibilities: develop global CMC regulatory strategies, contribute as CMC Lead on cross-functional teams, prepare and coordinate regulatory dossiers, support filings for development and marketed products, manage country-specific documentation, and drive compliance and continuous improvement. Requirements: BS in biological, pharmaceutical, chemical, or engineering sciences with 6+ years in pharmaceutical or healthcare sectors; advanced degrees (MS, Ph.D., Pharm.D.) preferred. Skills: strong understanding of biology, chemistry, manufacturing processes; experience with drug development, analytical development, or manufacturing; excellent communication and regulatory knowledge of global health authority laws. HighValue: CMC regulatory strategy, global filings, collaboration with therapeutic area teams, experience with regulatory inspections, applicable to biologics, synthetic or new modality products at various development stages. WorkSetup: multiple US locations (Pennsylvania, New Jersey); flexible across Beerse, Belgium, or Warsaw, Poland; specific travel requirements not detailed.