The role involves leading regulatory application strategies for in vitro diagnostic pharmaceuticals and medical devices to ensure patient access
Job Summary
The role involves leading regulatory application strategies for in vitro diagnostic pharmaceuticals and medical devices to ensure patient access.
Candidates must collaborate with global teams, government authorities like PMDA, and internal departments to secure and maintain product approvals.
Roche offers a supportive culture that encourages personal expression and provides opportunities for global career development through its international network.
Matching Summary
The role involves leading regulatory application strategies for in vitro diagnostic pharmaceuticals and medical devices to ensure patient access.
Skills & Requirements
Must-have
3+ years regulatory affairs experience
In vitro diagnostic medical device expertise
PMDA consultation and approval processes
English language proficiency required
Degree in life sciences or pharmacy
Nice-to-have
Programmed medical device knowledge
Growth mindset and out of box thinking
Leadership and junior staff mentoring
Global team collaboration skills
Logical reasoning and writing ability
Key Requirements
Minimum 3 years regulatory affairs experience
Degree in biochemistry, biology, immunology, or pharmacy
Experience with IVD and medical device applications