Sr Scientist Product Lead CMC RA

Role: Senior Scientist Product Lead for CMC Regulatory Affairs (Synthetic, New Modalities), focusing on global regulatory strategies and dossier preparation for innovative medicines. Responsibilities: develop and implement CMC regulatory plans, contribute as the regulatory lead on project teams, prepare and coordinate regulatory submissions for development and marketed products, support regulatory responses and inspections, and drive continuous compliance improvements. Requirements: BS in biological, pharmaceutical, chemical, or engineering sciences with 6+ years of industry experience; advanced degrees (MS, Ph.D., Pharm.D.) preferred; strong understanding of biology, chemistry, or engineering relevant to pharma; experience in drug development, analytical development, or manufacturing; excellent communication skills and knowledge of global health authority regulations. HighValue: expertise in CMC regulatory strategy, global filings (NDA/BLA/MAA/IND/CTA), development compounds, and lifecycle management of innovative medicines. WorkSetup: multiple US locations (Pennsylvania, New Jersey); international opportunities in Beerse (Belgium) or Warsaw (Poland). Travel details are not specified.