Global Regulatory CMC Lead, Small Molecules

Excelya; Palaiseau; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Excelya is seeking a consultant to lead the global Regulatory CMC strategy for a small molecule, focusing on Module 3 preparation, Marketing Authorization Applications, and global health authority interactions. The role requires strong knowledge of FDA/EMA/ICH and proven experience in Module 3 submissions, in a cross-functional, international setting.

The successful candidate will manage regulatory risks, work with cross-functional teams, and ensure submission content is scientifically robust

Qualifications

• Solid experience in Regulatory CMC within the pharmaceutical industry, strong expertise in small molecules, proven experience with Module 3 and global Marketing Authorization Applications/NDA submissions.
• Strong knowledge of FDA, EMA and ICH requirements.
• Fluent English required.

Responsabilités

• Lead the global Regulatory CMC strategy and support Marketing Authorization Applications
• Lead/review Module 3 preparation and submission activities
• Support interactions with FDA, EMA and other Health Authorities, including responses to questions
• Identify regulatory risks and define appropriate mitigation strategies
• Operate effectively within a global and cross-functional matrix environment
• Ensure alignment of CMC regulatory strategies with overall development and commercialization objectives
• Coordinate with cross-functional teams including CMC, Quality, Manufacturing, Regulatory and Technical teams
• Ensure consistency, scientific robustness, and regulatory compliance of submission content
• Provide strategic input regarding regulatory positioning and negotiation approaches
• Ensure compliance with applicable ICH and global regulatory requirements

Connaissances

Regulatory CMC

FDA/EMA/ICH knowledge

Stakeholder management

Cross-functional collaboration

English proficiency

Formation

Master’s degree in Pharmacy, Chemistry, Life Sciences or related

Description du poste

Excelya is seeking a consultant to lead the global Regulatory CMC strategy for a small molecule, focusing on Module 3 preparation, Marketing Authorization Applications, and global health authority interactions. The role requires strong knowledge of FDA/EMA/ICH and proven experience in Module 3 submissions, in a cross-functional, international setting.

The successful candidate will manage regulatory risks, work with cross-functional teams, and ensure submission content is scientifically robust