Senior CMC Regulatory Strategy Lead — Small Molecules

Excelya Group; Saclay; On-site; EUR 90,000 - 130,000; Full time

Job summary

Excelya Group in France seeks a Senior CMC Regulatory Consultant to lead the global CMC regulatory strategy for a late-phase small molecule asset, including MAA preparation, with cross-functional collaboration to ensure submission excellence.

You will coordinate with affiliate teams, manage the CMC dossier with the writing team, and guide regulatory input across EMA, FDA, and ICH frameworks, while maintaining timelines and high-quality deliverables.

Qualifications

• Degree in pharmacy, chemistry, pharmaceutical sciences, or related field.
• Extensive experience in CMC regulatory affairs focused on small molecule lifecycle management.
• Strong knowledge of EMA, FDA, ICH and lifecycle management.
• Proven ability to lead CMC regulatory projects with cross-functional teams.
• Excellent communication, analytical and organizational skills.
• Fluency in English; French language skills are a plus.

Responsibilities

• Lead the global CMC Regulatory strategy for one small molecule asset (late phase; MAA under preparation).
• Define, develop, own and execute the global CMC Regulatory strategy to maximize regulatory outcomes.
• Enable accelerated product development pathways to speed delivery to patients.
• Manage timely delivery of regulatory documents with project management discipline.
• Lead CMC strategy for agency interactions (including BB preparation).
• Represent CMC Regulatory in cross-functional meetings as needed.
• Provide CMC Regulatory support to the Reg CMC writing team for country requirements.
• Liaise with Local Affiliates to develop efficient regulatory strategies for dossier delivery.
• Generate gap analyses and risk management for submissions in core markets.

Skills

CMC regulatory affairs

Small molecule lifecycle

Global regulatory frameworks

Project leadership

Regulatory submissions

Fluent English

Education

Degree in pharmacy, chemistry, pharmaceutical sciences, or related field

Job description

Excelya Group in France seeks a Senior CMC Regulatory Consultant to lead the global CMC regulatory strategy for a late-phase small molecule asset, including MAA preparation, with cross-functional collaboration to ensure submission excellence.

You will coordinate with affiliate teams, manage the CMC dossier with the writing team, and guide regulatory input across EMA, FDA, and ICH frameworks, while maintaining timelines and high-quality deliverables.