Description
Summary
- 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
Minimum Requirements
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.
LI-KD1
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. Key internal leader and driver of regulatory policy and strategy for assigned medical devices. In cooperation with Global Device Regulatory team, leads...
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