Sr Scientist Product Lead CMC RA
Listed on 2026-09-14
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Pharmaceutical
Pharmaceutical Science/ Research, Pharmaceutical Manufacturing, Regulatory Compliance Specialist
Role
Senior Scientist Product Lead CMC RA - Synthetics, New Modalities, focusing on regulatory chemistry, manufacturing, and controls (CMC) for innovative medicines.
Responsibilitiesdevelop 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.
RequirementsBS in biological, pharmaceutical, chemical, or engineering sciences with 6+ years in pharmaceutical or healthcare sectors; advanced degrees (MS, Ph.D., Pharm.D.) preferred.
Skillsstrong understanding of biology, chemistry, manufacturing processes; experience with drug development, analytical development, or manufacturing; excellent communication and regulatory knowledge of global health authority laws.
High ValueCMC 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.
Work Setupmultiple US locations (Pennsylvania, New Jersey); flexible across Beerse, Belgium, or Warsaw, Poland; specific travel requirements not detailed.
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