Manager, Japan Regulatory Affairs Strategy, Devices & Pharma

• 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

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.

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