Senior Regulatory CMC Consultant

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

Join Excelya, a dynamic and innovative company committed to excellence and collaboration in the field of translational research.Our global team of experts are the powerful force behind our success. When you work at Excelya, you become part of an international network that nurtures your talent, builds your skills and recognizes your value.

The selected consultant will play a critical role in leading the global Regulatory CMC strategy for a small molecule product, with a particular focus on Module 3 preparation, Marketing Authorization Applications, global health authority interactions, and regulatory submission readiness

Missions

• 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

Education : Master’s degree or equivalent in Pharmacy, Chemistry, Life Sciences, Biotechnology, Pharmaceutical Sciences or a related scientific discipline.

Experience : 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.

Skills : Strong knowledge of FDA, EMA and ICH requirements. Experience with international markets such as China, Japan, Brazil and Canada is a plus. Strong strategic thinking, stakeholder management and cross-functional collaboration skills.

Langages : Fluent English required

About Excelya

At Excelya, we combine a passion for science with a strong team spirit to redefine excellence in healthcare.

We are an ambitious healthcare company bringing together more than 900 employees across Europe, with the ambition of becoming the leading mid-sized CRO in Europe, while providing the best possible employee experience.

Our integrated service model, combining Consulting, Functional Service Provider (FSP), and Full-Service solutions, gives you the opportunity to work on a wide variety of high-value projects. You will collaborate with recognized experts and make a meaningful contribution to improving the patient journey.

At Excelya, caring is at the heart of everything we do. We promote equal opportunities and are committed to building a diverse, equitable, and inclusive working environment where everyone can thrive, be recognized, and fully contribute to a shared mission. Your challenges become our collective mission. Together, we turn ambitious ideas into tangible achievements, the Excelya way.

Join us today and become an Excelyate!