Manager, Japan Regulatory Affairs Strategy, Devices & Pharma
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Job Title
Manager, Japan Regulatory Affairs Strategy, Devices & Pharma
Requisition
JR000014318 Manager, Japan Regulatory Affairs Strategy, Devices & Pharma (Open)
Location
Tokyo, Japan
Additional Locations
Job Description Summary
Job Description
Summary
Supports the Global Regulatory Lead (GRL)/ in the development & execution of the regulatory strategy
Responsible for operational and tactical project management to ensure satisfactory completion of regulatory milestones
In cooperation with Global Device Regulatory team and the Global Regulatory Project team, leads activities to develop and implement regulatory strategies to secure global licenses and approvals.
Manages the content of global regulatory dossiers. Key internal leader and driver of regulatory policy and strategy for assigned development and marketed products.
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, guidance’s, 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 drug/device development experience with 3 years of 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 regulatory submissions associated with pharmaceutical products and medical devices as well 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.