CMC RA Manager- Japan
- 〜 1200万円
- Role Summary:
The CMC RA Manager (CMC Dossier Leader) provides CMC regulatory input and strategies to directly support development projects and marketed products within Pharmaceutical Diagnostics with the main focus on Japanese submissions. The key responsibility of CMC RA Manager is to develop and maintain the Quality sections of the product dossiers throughout the entire life cycle of a product (Module 1.2, 2.3 and Module 3).
Bachelor’s Degree & a minimum of 5 years of experience in a diagnostic or pharmaceutical industry or medical device or government / government relations.
Ability to prioritize, plan & evaluate deliverables to established strategic goals.
Demonstrated experience of operating in a highly-regulated environment. Capable of applying analytical skills in a CMC regulatory environment.
Has experience working within a matrix organization and has strong interpersonal and influencing skills to work across disciplines. Has the capability to influence managers and help drive decisions at a project level.
Demonstrated knowledge & experience in scientifically related field e.g. pharmaceutical sciences, chemistry and analytical sciences.
Experience in electronic document management and Quality management systems.
Good verbal and written communication and presentation skills with the ability to communicate issues in English in an easy to understand manner.