Senior Regulatory CMC Consultant

Excelya·Saclay, Francesenior

In short

→Liderar la estrategia reguladora CMC global para un medicamento de pequeña molécula.
→Preparar y revisar el módulo 3, presentar solicitudes de autorización y gestionar interacciones con FDA, EMA y otras autoridades.
→Destacar por liderar estrategias complejas en entornos globales y multidisciplinarios.

Fluent English required

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What they ask for

✓Master en Farmacia, Química, Ciencias de la Vida, Biotecnología o disciplina relacionada.
✓Experiencia sólida en CMC reguladora en la industria farmacéutica.
✓Experto en moléculas pequeñas y en el módulo 3 de presentaciones regulatorias.
✓Conocimiento avanzado de requisitos de FDA, EMA e ICH.
✓Habilidades de pensamiento estratégico y gestión de stakeholders.
✓Inglés fluido requerido.

Don't tick every box? That's normal — your free dossier shows your gaps and how to cover them in the interview.

FDAEMAICHModule 3NDAMarketing Authorization ApplicRegulatory SubmissionsCMC Regulatory StrategyCross-functional CollaborationGlobal Health Authorities

Who should you write to at Excelya?

Your free dossier identifies the people who'd interview you — their background, what they value, and how to reach out so you stand out before applying.

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. 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. Benefits 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!

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