Manager Japan Regulatory Affairs Strategy Devices & Pharma

**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. #LI-KD1