Global CMC Regulatory Lead — Small Molecule (Late-Phase)

Excelya; France; Hybride; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Excelya in France is seeking a Senior CMC Regulatory Consultant specializing in small molecule lifecycle management to join our global team. You will provide regulatory input across development to post-marketing, leading the CMC strategy and delivering robust dossiers.

The role requires strong knowledge of EMA, FDA, and ICH frameworks, and the ability to lead multidisciplinary projects while maintaining effective communication. English fluency is essential; French is a plus.

Qualifications

• Extensive experience in CMC regulatory affairs for small molecule lifecycle management.
• Strong knowledge of EMA, FDA, ICH regulatory frameworks.
• 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.

Responsabilités

• 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 while maximizing regulatory outcomes.
• Ensure CMC strategies enable accelerated product development pathways.
• Manage project timelines and ensure timely regulatory documents delivery.
• Lead CMC strategy for agency interactions including BB preparation.
• Represent CMC Regulatory in cross-functional meetings as needed.
• Provide CMC Regulatory support to the regulatory CMC writing team.
• Liaise with Local Affiliates to align strategies with country requirements.
• Generate gap analyses and risk management for submissions in core markets.
• Compile regulatory documents for submissions on time and meeting country requirements.

Connaissances

CMC regulatory affairs

Small molecule lifecycle

Global regulatory frameworks

Project leadership

Communication skills

Analytical mindset

Organizational skills

English fluency

French desirable

Formation

Degree in pharmaceutical sciences

Description du poste

Excelya in France is seeking a Senior CMC Regulatory Consultant specializing in small molecule lifecycle management to join our global team. You will provide regulatory input across development to post-marketing, leading the CMC strategy and delivering robust dossiers.

The role requires strong knowledge of EMA, FDA, and ICH frameworks, and the ability to lead multidisciplinary projects while maintaining effective communication. English fluency is essential; French is a plus.