Global CMC Regulatory Lead — Small Molecules

EXCELYA; Saclay; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Excelya is seeking a Senior CMC Regulatory Consultant to lead the CMC regulatory strategy for a late-phase small molecule asset (MAA under preparation) and to manage the CMC Dossier with support from the regulatory CMC writing team.

You will collaborate with cross-functional teams and global affiliates to ensure robust regulatory strategies, submission excellence, and timely regulatory deliverables across core markets.

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 frameworks and lifecycle management.
• Proven ability to lead CMC regulatory projects across multidisciplinary teams.

Responsabilités

• Lead the global CMC Regulatory strategy for the asset (late phase; MAA under preparation).
• Define and own global CMC Regulatory strategy and ensure favorable regulatory outcomes.
• Represent CMC Regulatory in cross-functional governance meetings and agency interactions.
• Provide regulatory support to writing teams and liaise with local affiliates to meet country requirements and timelines.
• Generate risk analyses and prepare regulatory documents for core market submissions.

Connaissances

CMC regulatory affairs

Regulatory leadership

Cross-functional collaboration

Excellent communication

English fluent

Formation

Pharmacy degree

Description du poste

Excelya is seeking a Senior CMC Regulatory Consultant to lead the CMC regulatory strategy for a late-phase small molecule asset (MAA under preparation) and to manage the CMC Dossier with support from the regulatory CMC writing team.

You will collaborate with cross-functional teams and global affiliates to ensure robust regulatory strategies, submission excellence, and timely regulatory deliverables across core markets.