The role involves leading regulatory approval strategies for in vitro diagnostic medicines and medical devices in collaboration with global teams
Job Summary
The role involves leading regulatory approval strategies for in vitro diagnostic medicines and medical devices in collaboration with global teams.
Candidates must possess a scientific degree in fields such as biochemistry, immunology, or pharmacology to interpret complex technical data.
Roche offers a supportive culture that encourages personal expression and provides opportunities for global career progression through internal programs.
Matching Summary
The role involves leading regulatory approval strategies for in vitro diagnostic medicines and medical devices in collaboration with global teams.
Skills & Requirements
Must-have
3+ years regulatory affairs experience
In vitro diagnostic medical device knowledge
English language proficiency required
PMDA and MHLW liaison experience
Scientific degree in relevant field
Nice-to-have
Programmed medical device experience
Growth mindset and out of box thinking
Leadership and junior staff development
Global team collaboration skills
Logical reasoning and writing ability
Key Requirements
Minimum 3 years of regulatory application experience
Degree in biochemistry, biology, immunology, or related science
Fluent English reading and writing capabilities
Experience with PMDA consultation and administrative negotiations