In your new role you will have a key role in overseeing RA CMC projects within the regulatory department. You will coordinate and align assigned projects during product development phase as well as product lifecycle with various parties involved, e.g., internal RA CMC groups (DS, DP, Analytics), production, supply chain and license partners. This includes the following tasks:
- Coordinate compilation of CMC part of briefing books for health authority interactions and support meeting preparation
- Oversee compilation of quality part of IMPDs for CTA applications
- Plan, coordinate and ensure preparation of Module 3 parts within agreed timelines for defined regions together with assigned RA CMC Managers
- Coordinate and drive region specific adaptations of CMC dossiers and associated activities together with internal departments, license partners or consultants
- Establish strategies and plans for major lifecycle projects, like tech transfers or launches of additional dosage forms
- Develop global submission plan strategies in the context of global rollout of a product together with business development, supply chain and involved license partners
- Oversee global registration status and maintain respective data bases
In addition to overseeing your assigned RA CMC projects you will contribute to continuous improvement projects for CMC dossier compilation, tracking tools and establishment of lifecycle management activities.