Manager, Japan Regulatory Affairs Strategy, Devices & Pharma

About the role

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