Develop local regulatory strategy and lead the strategic discussion with related stakeholders, including Business Unit, R&D, Clinical Affairs, and Market Access & Reimbursement to accelerate projects and fast serve patients.
Proactively identify risks within regulatory strategies, plans, products and propose alternate approaches.
Provide interpretation of local regulations to BU partners and ensure necessary requirements are fully deployed.
Stay informed of new regulations and technologies relevant to endovascular therapeutics.
Plan and execute product registration aligned with local business needs.
Maintain current registration approvals accordingly.
Manage interactions with MHLW/PMDA and maintain a productive working relationship.
Review and Author productregistration/reimbursementdocument.
Proceed regulatory assessment and promotional material review.
Oversee product registration and RA administration activities.