Manager, Japan Regulatory Affairs Strategy, Devices

•     Holds responsibility for medical device(s) and supports the Global Regulatory Lead (GRL)/ in the development & execution of the regulatory strategy

•     In cooperation with Global Device Regulatory team, leads activities to develop and implement regulatory strategies to secure global medical device licenses and approvals.

•     Manages the content of global regulatory dossiers.  Key internal leader and driver of regulatory policy and strategy for assigned medical devices.

•           Supports fore-mentioned regulatory activities for pharmaceutical products as needed.

•     Serves in supporting as Health Authority (HA) liaison with MHLW/PMDA for routine communications in support of filings including complete and timely responses during application review/inspection phases.

•     Advises internal customers who may contribute to communication on Regulatory issues including non-clinical/Clinical Development, and others such as Commercial and Quality.

•     Recommends and implements changes to projects based on knowledge and expertise, accurate interpretation of health authority regulations, guidances, as well as corporate policies and management-related considerations

•           Accountable for ensuring that corporate goals are met within the scope of the project

•           Participates in departmental and corporate initiatives

Education/Experience/Skills

•     Bachelor degree; preferably in a pharmacy, scientific or technical field; advanced scientific-related degree strongly preferred

•           5 years Medical devices (Class III or IV) regulatory activities experience.

•     Excellent verbal and written communication skills as well as strong interpersonal skills and tactful negotiation skills.

•     Functions independently in negotiation and decision-making for project related issues that have cross-functional impact.

•     Uses problem solving skills to separate and combine tasks into efficient workflow and effectively/creatively solve problems

•     Hands on experience with preparation of Medical device applications, STED and Briefing book for PMDA meeting.

•     Japanese native speaker, and also English capability especially in reading, writing and verbal communication skill

Preferred qualification

•           Drug regulatory activities experience

•           Medical devices/Drug development experience

•           On-line regulatory document submission through Gateway

Working conditions

•           Candidate must be willing to travel up to 10% of time.

•           Overseas travel as needed if qualified for the task.

•           A hybrid work structure where employees can work remotely or from the office, as needed.

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