Associate Director Technical Integrator
The mission of this company is to transform individual lives and fundamentally change the way diseases are interpreted, managed and in the end prevented. In over 150 countries the company is bringing innovative science and together with the most creative minds in the industry think differently about diseases. Trying to achieve the best possible results for their health.
As Associate Director Dossier Development you will be responsible for developing the technical eCTD sections to support Regulatory CMC dossier applications. You coordinate and provide technical oversight for the generation of the CMC dossier of marketing and clinical trial submissions whilst coordinating the timeline, virtual document and the generation of the Quality module.
- Author of sections of the CMC dossier, evaluate and ensure that the final version comply with Regulatory requirements
- Support the technical functions in the development of responses to health authority inquiries in support of clinical trials and major applications
- Contribute to dossier strategy and complex product development plan creation at a compound level
- Identify business improvement areas and lead implementation of improvements
- Drive structured improvements of functional processes such as quality, costs, time and asset utilization
- Managing several complex projects with potentially accelerated priority
- Minimal Bachelor in a relevant field
- Background in Biologics is preferred
- Hands-on experience with Module 3 Dossier Writing
- 5 years' of experience in RA CMC
- Good communication skills for internal alignment