Global Regulatory CMC Lead for Small Molecule NDA

Excelya; Saclay; On-site; EUR 95,000 - 150,000; Full time

Job summary

Excelya in Île-de-France is seeking a senior Regulatory CMC consultant to lead the global strategy for small molecule programs, with emphasis on Module 3 preparation and MAAs. You will coordinate with CMC, Quality, Manufacturing and Regulatory teams to ensure submission readiness.

The role requires solid Regulatory CMC experience, strong FDA/EMA/ICH knowledge, and excellent cross-functional collaboration in an international environment. Fluent English is mandatory.

Qualifications

• Master’s degree or equivalent in Pharmacy, Chemistry, Life Sciences, Biotechnology, Pharmaceutical Sciences or a related scientific discipline.
• 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; experience with international markets is a plus.
• Fluent English required.
• Excellent stakeholder management and cross-functional collaboration skills.

Responsibilities

• 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
• 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

Skills

Regulatory CMC expertise

Module 3 submissions

Strategic thinking

Stakeholder management

Cross-functional collaboration

English fluency

Education

Master’s degree in Pharmacy/ Chemistry/ Life Sciences/ Biotechnology/ Pharmaceutical Sciences

Tools

Regulatory submission processes

ICH guidelines

Global health authority interactions

Job description

Excelya in Île-de-France is seeking a senior Regulatory CMC consultant to lead the global strategy for small molecule programs, with emphasis on Module 3 preparation and MAAs. You will coordinate with CMC, Quality, Manufacturing and Regulatory teams to ensure submission readiness.

The role requires solid Regulatory CMC experience, strong FDA/EMA/ICH knowledge, and excellent cross-functional collaboration in an international environment. Fluent English is mandatory.