Sr Scientist Product Lead CMC RA

Role: Senior Scientist Product Lead CMC RA - Synthetics, New Modalities, focusing on global CMC regulatory strategies for innovative medicines. Responsibilities: develop and implement regulatory dossiers and strategies for development compounds, support global filings, prepare and coordinate regulatory submissions and responses to health authorities, and contribute to CMC team initiatives. Collaborates with cross-functional teams including Therapeutic Area Regulatory Affairs and Quality; may serve as Regulatory CMC Lead on CMC teams and represent CMC RA in global regulatory discussions. Requirements: BS in biological, pharmaceutical, chemical, or engineering sciences with 6+ years of industry experience; advanced degrees (MS, Ph.D., Pharm.D.) preferred. Knowledge of biology, chemistry, engineering relevant to pharma, drug development or manufacturing, and global health authority regulations is essential. Skills include strong communication, attention to detail, and ability to navigate complex regulatory environments. High-Value: focus on innovative medicines, global regulatory strategy, CMC dossier preparation, and cross-functional collaboration across multiple countries (US, Belgium, Poland). Work setup: multiple locations, with international scope.