Senior CMC Regulatory Lead – Small Molecule Lifecycle

Excelya; United States; Remote; USD 120,000 - 190,000; Full time

Job summary

Excelya is seeking a Senior CMC Regulatory Consultant to drive lifecycle management for a small molecule asset. You will shape global CMC strategies, coordinate cross-functional teams, and lead regulatory interactions to optimize development timelines.

The role emphasizes collaboration with global teams, regulatory writing support, and ensuring compliance with EMA, FDA, and ICH guidelines. English fluency is essential; French is a plus.

Qualifications

• Degree in pharmacy, chemistry, pharmaceutical sciences or related field.
• Extensive experience in CMC regulatory affairs for small molecules lifecycle management.
• Strong knowledge of global regulatory frameworks (EMA, FDA, ICH) and lifecycle management principles.
• Proven ability to lead CMC regulatory projects and collaborate with multidisciplinary teams.
• Excellent communication, analytical, and organizational skills.
• Fluency in English; French language skills are a plus.

Responsibilities

• Lead the global CMC regulatory strategy for a small molecule asset (late stage; MAA under preparation).
• Define, develop, own and execute the global CMC regulatory strategy to maximize outcomes.
• Enable accelerated development pathways to speed up delivery to patients.
• Manage and deliver regulatory documents with high quality and on time.
• Lead the CMC strategy for agency interactions and core meetings for the asset.

Skills

CMC regulatory affairs

Project leadership

Cross-functional collaboration

Regulatory writing

English fluency

French language

Education

Bachelor's degree in pharmacy, chemistry, pharmaceutical sciences

Job description

Excelya is seeking a Senior CMC Regulatory Consultant to drive lifecycle management for a small molecule asset. You will shape global CMC strategies, coordinate cross-functional teams, and lead regulatory interactions to optimize development timelines.

The role emphasizes collaboration with global teams, regulatory writing support, and ensuring compliance with EMA, FDA, and ICH guidelines. English fluency is essential; French is a plus.