Senior Regulatory CMC Project lead

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

About the Job

About the JobAt Excelya, where Audacity, Care, and Energy are at the core of everything we do, we are seeking a Senior CMC Regulatory Consultant specializing in small molecules lifecycle management to join our dynamic team.This role involves providing expert regulatory input throughout the lifecycle of small molecule products, from development to post-marketing activities. As a Senior Consultant, you will work closely with cross-functional teams to ensure robust regulatory strategies, compliance, and submission excellence.

Main Responsibilities

• Leading the global CMC Regulatory strategy for one small molecule asset (late phase; MAA under preparation)
• Defining, developing, owning and executing the global CMC Regulatory strategy whilst maximizing the regulatory outcomes for this asset
• Ensure that CMC Regulatory strategies are an enabler to potential accelerated product development pathways to ensure speed up product delivery to patients
• Effective project management skills to ensure high quality and timely delivery of regulatory documents
• Leading the CMC strategy for all agency interactions for the allocated asset (including the preparation of the BB)
• Represent CMC Regulatory on the asset cross-functional technical, regulatory and governance meetings as needed
• Provide CMC Regulatory support to the Reg CMC technical writing team in relation to the respective country requirements
• Liaise with the Local Affiliate of the respective countries to develop efficient regulatory strategies to deliver the CMC Dossier in line with country requirements and agreed timelines
• Generate gap analysis and risk management support for each submission in the core markets as needed
• Compile regulatory documents in support of each submission in the core markets on time and in line with country requirements

Requirements

• Degree in pharmacy, chemistry, pharmaceutical sciences, or related field
• Extensive experience in CMC regulatory affairs focused on small molecule lifecycle management, preferably within pharmaceutical industry or consultancy
• 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

Benefits

Why Join Us?At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.Here’s what makes us unique— We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience. Our one-stop provider service model—offering full-service, funct