About the Job

The CMC Dossier Sciences department within client R&D Global CMC Development organization has

critical roles and responsibilities in leading the preparation of CMC dossiers for regulatory submissions to

enable advancement of company's product development through clinical phases to market authorization.

We are seeking qualified individuals to join the team, which focus on supporting client's innovative

pipeline of Mammalian products.



Main Responsibilities:

"Drive AI-powered solutions and digital tools to transform how we prepare CMC regulatory

documents

" Lead, coordinate, and manage CMC dossier preparation and development processes.

Drive alignment between dossier strategy and CMC activities as a core CMC team

member, ensuring data supports expedited pathways to clinic and patients

" Lead CMC sub team (Dossier Su...