Global Regulatory CMC Lead - Module 3 & NDA Strategy

Excelya; Saclay; Sur place; EUR 90 000 - 140 000; Plein temps

Résumé du poste

Excelya is seeking a seasoned Regulatory CMC consultant to lead the global strategy for small molecule products, focusing on Module 3 preparation and regulatory submission readiness. The role involves interactions with FDA, EMA and other health authorities, ensuring robust, compliant submissions across international markets.

We value strong regulatory strategy, cross-functional collaboration, and the ability to navigate complex submissions with scientific rigor.

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, with small molecules and Module 3.
• Proven track record with global Marketing Authorization Applications / NDA submissions.
• Strong knowledge of FDA, EMA and ICH requirements; exposure to multiple international markets is a plus.

Responsabilités

• Lead the global Regulatory CMC strategy and support MAAs.
• Lead/review Module 3 preparation and submission activities.
• Coordinate with Health Authorities (FDA, EMA) and other stakeholders.
• Identify regulatory risks and define mitigation strategies.

Connaissances

Regulatory CMC

Module 3

Global MAAs

Regulatory strategy

Formation

Master's degree (Pharmacy/ Chemistry/ Life Sciences)

Description du poste

Excelya is seeking a seasoned Regulatory CMC consultant to lead the global strategy for small molecule products, focusing on Module 3 preparation and regulatory submission readiness. The role involves interactions with FDA, EMA and other health authorities, ensuring robust, compliant submissions across international markets.

We value strong regulatory strategy, cross-functional collaboration, and the ability to navigate complex submissions with scientific rigor.