Global Regulatory CMC Lead – Small Molecules MAAs

Excelya; Saclay; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Excelya is seeking a seasoned Regulatory CMC Consultant to lead global strategy for a small molecule product, focusing on Module 3 preparation and Marketing Authorization Applications. You will liaise with FDA, EMA and other health authorities, identifying risks and guiding mitigation strategies across a global matrix organization.

Applicants should have solid Regulatory CMC experience in pharma, with Module 3 and NDA submissions, and be fluent in English.

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.
• 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 strategy

Stakeholder mgmt

Cross-functional collab

Strategic thinking

English fluency

Regulatory CMC

Formation

Master's degree in Pharmacy/related life science

Description du poste

Excelya is seeking a seasoned Regulatory CMC Consultant to lead global strategy for a small molecule product, focusing on Module 3 preparation and Marketing Authorization Applications. You will liaise with FDA, EMA and other health authorities, identifying risks and guiding mitigation strategies across a global matrix organization.

Applicants should have solid Regulatory CMC experience in pharma, with Module 3 and NDA submissions, and be fluent in English.