Global Regulatory CMC Lead - Small Molecule

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

Job summary

Excelya Group in Saclay (Île-de-France) is seeking a senior Regulatory CMC consultant to lead the global strategy for small molecule products, focusing on Module 3 preparation and Marketing Authorization Applications. You will coordinate with CMC, Quality, Manufacturing and Regulatory teams to ensure alignment with development and commercialization objectives.

The ideal candidate has solid Regulatory CMC experience, strong knowledge of FDA, EMA and ICH requirements, and fluency in English.

Qualifications

• Master’s degree or equivalent in Pharmacy, Chemistry, Life Sciences, Biotechnology, Pharmaceutical Sciences or related field.
• 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.

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.
• 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.

Skills

Regulatory strategy

Regulatory submissions

FDA/EMA/ICH knowledge

Stakeholder management

Cross-functional collaboration

English fluency

Education

Master’s degree in Pharmacy/chemistry/life sciences

Job description

Excelya Group in Saclay (Île-de-France) is seeking a senior Regulatory CMC consultant to lead the global strategy for small molecule products, focusing on Module 3 preparation and Marketing Authorization Applications. You will coordinate with CMC, Quality, Manufacturing and Regulatory teams to ensure alignment with development and commercialization objectives.

The ideal candidate has solid Regulatory CMC experience, strong knowledge of FDA, EMA and ICH requirements, and fluency in English.