Senior Manager/Associate Director, International Regulatory Affairs

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width="305" height="46" alt="" /></p><p style="margin: 0.0pt;text-align: center;"><span style="font-family: Arial;font-size: 10.0pt;"> </span></p><p style="margin: 0.0pt;text-align: center;"><span style="font-family: Arial;font-size: 10.0pt;"> </span></p><p style="margin: 0.0pt;text-align: center;"><span style="font-family: Arial;font-size: 10.0pt;"> </span></p><h1 style="margin: 0.0pt;text-align: center;"><span style="font-family: Arial;font-size: 14.0pt;font-weight: bold;">JOB DESCRIPTION</span></h1><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;"> </span></p><div style="text-align: center;"><table cellspacing="0" cellpadding="0" style="border-collapse: collapse;margin: 0 auto;width: 445.6pt;"><tbody><tr><td style="background-color: rgb(224,224,224);padding-left: 4.9pt;padding-right: 5.03pt;vertical-align: top;width: 165.6pt;border-width: 1.0pt 0.75pt 0.75pt 1.0pt;border-color: rgb(0,0,0);border-style: solid;"><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;font-weight: bold;">Job Title:</span><span style="font-family: Arial;font-size: 12.0pt;"> </span></p></td><td style="padding-left: 5.03pt;padding-right: 4.9pt;vertical-align: top;width: 257.4pt;border-width: 1.0pt 1.0pt 0.75pt 0.75pt;border-color: rgb(0,0,0);border-style: solid;"><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;">Senior Manager</span><span style="font-family: Arial;font-size: 12.0pt;">,</span><span style="font-family: Arial;font-size: 12.0pt;"> International Regulatory Affairs</span></p></td></tr><tr><td style="background-color: rgb(224,224,224);padding-left: 4.9pt;padding-right: 5.03pt;vertical-align: top;width: 165.6pt;border-width: 0.75pt 0.75pt 0.75pt 1.0pt;border-color: rgb(0,0,0);border-style: solid;"><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;font-weight: bold;">Department / </span><span style="font-family: Arial;font-size: 12.0pt;font-weight: bold;">Cost</span><span style="font-family: Arial;font-size: 12.0pt;font-weight: bold;"> </span><span style="font-family: Arial;font-size: 12.0pt;font-weight: bold;">Center</span><span style="font-family: Arial;font-size: 12.0pt;font-weight: bold;">: </span></p></td><td style="padding-left: 5.03pt;padding-right: 4.9pt;vertical-align: top;width: 257.4pt;border-width: 0.75pt 1.0pt 0.75pt 0.75pt;border-color: rgb(0,0,0);border-style: solid;"><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;">Regulatory – 2</span><span style="font-family: Arial;font-size: 12.0pt;">10</span></p></td></tr><tr><td style="background-color: rgb(224,224,224);padding-left: 4.9pt;padding-right: 5.03pt;vertical-align: top;width: 165.6pt;border-width: 0.75pt 0.75pt 0.75pt 1.0pt;border-color: rgb(0,0,0);border-style: solid;"><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;font-weight: bold;">Reports to (Job Title):</span><span style="font-family: Arial;font-size: 12.0pt;"> </span></p></td><td style="padding-left: 5.03pt;padding-right: 4.9pt;vertical-align: top;width: 257.4pt;border-width: 0.75pt 1.0pt 0.75pt 0.75pt;border-color: rgb(0,0,0);border-style: solid;"><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;">Head of </span><span style="font-family: Arial;font-size: 12.0pt;">APAC </span><span style="font-family: Arial;font-size: 12.0pt;">Regulatory Affairs</span></p></td></tr><tr><td style="background-color: rgb(224,224,224);padding-left: 4.9pt;padding-right: 5.03pt;vertical-align: top;width: 165.6pt;border-width: 0.75pt 0.75pt 0.75pt 1.0pt;border-color: rgb(0,0,0);border-style: solid;"><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;font-weight: bold;">Job Code:</span></p></td><td style="padding-left: 5.03pt;padding-right: 4.9pt;vertical-align: top;width: 257.4pt;border-width: 0.75pt 1.0pt 0.75pt 0.75pt;border-color: rgb(0,0,0);border-style: solid;"><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;"> </span></p></td></tr><tr><td style="background-color: rgb(224,224,224);padding-left: 4.9pt;padding-right: 5.03pt;vertical-align: top;width: 165.6pt;border-width: 0.75pt 0.75pt 0.75pt 1.0pt;border-color: rgb(0,0,0);border-style: solid;"><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;font-weight: bold;">Location:</span><span style="font-family: Arial;font-size: 12.0pt;"> </span></p></td><td style="padding-left: 5.03pt;padding-right: 4.9pt;vertical-align: top;width: 257.4pt;border-width: 0.75pt 1.0pt 0.75pt 0.75pt;border-color: rgb(0,0,0);border-style: solid;"><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;">Tokyo</span></p></td></tr><tr><td style="background-color: rgb(224,224,224);padding-left: 4.9pt;padding-right: 5.03pt;vertical-align: top;width: 165.6pt;border-width: 0.75pt 0.75pt 1.0pt 1.0pt;border-color: rgb(0,0,0);border-style: solid;"><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;font-weight: bold;">Date Prepared:</span><span style="font-family: Arial;font-size: 12.0pt;"> </span></p></td><td style="padding-left: 5.03pt;padding-right: 4.9pt;vertical-align: top;width: 257.4pt;border-width: 0.75pt 1.0pt 1.0pt 0.75pt;border-color: rgb(0,0,0);border-style: solid;"><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;">February</span><span style="font-family: Arial;font-size: 12.0pt;"> 202</span><span style="font-family: Arial;font-size: 12.0pt;">5</span></p></td></tr></tbody></table></div><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;font-weight: bold;"> </span></p><div style="text-align: center;"><table cellspacing="0" cellpadding="0" style="border-collapse: collapse;margin: 0 auto;width: 442.9pt;"><tbody><tr style="height: 32.8pt;"><td style="background-color: rgb(224,224,224);padding-left: 4.9pt;padding-right: 4.65pt;vertical-align: top;width: 138.6pt;border-width: 1.0pt 1.5pt 1.0pt 1.0pt;border-color: rgb(0,0,0);border-style: solid;"><p style="margin: 0.0pt;text-align: center;"><span style="font-family: Arial;font-size: 10.0pt;font-weight: bold;"> </span></p><p style="margin: 0.0pt;text-align: center;"><span style="font-family: Arial;font-size: 10.0pt;font-weight: bold;"> Full-Time     </span><span style="font-family: Arial;font-size: 10.0pt;font-weight: bold;"> Part-Time</span></p><p style="margin: 0.0pt;text-align: center;"><span style="font-family: Arial;font-size: 10.0pt;font-weight: bold;"> </span></p></td><td style="background-color: rgb(224,224,224);padding-left: 4.65pt;padding-right: 4.65pt;vertical-align: top;width: 133.2pt;border-width: 1.0pt 1.5pt 1.0pt 1.5pt;border-color: rgb(0,0,0);border-style: solid;"><p style="margin: 0.0pt;text-align: center;"><span style="font-family: Arial;font-size: 10.0pt;font-weight: bold;"> </span></p><p style="margin: 0.0pt;text-align: center;"><span style="font-family: Arial;font-size: 10.0pt;font-weight: bold;"> Regular     </span><span style="font-family: Arial;font-size: 10.0pt;font-weight: bold;"> Temporary</span></p><p style="margin: 0.0pt;text-align: center;"><span style="font-family: Arial;font-size: 10.0pt;font-weight: bold;"> </span></p></td><td style="background-color: rgb(224,224,224);padding-left: 4.65pt;padding-right: 4.9pt;vertical-align: top;width: 137.7pt;border-width: 1.0pt 1.0pt 1.0pt 1.5pt;border-color: rgb(0,0,0);border-style: solid;"><p style="margin: 0.0pt;text-align: center;"><span style="font-family: Arial;font-size: 10.0pt;font-weight: bold;"> </span></p><p style="margin: 0.0pt;text-align: center;"><span style="font-family: Arial;font-size: 10.0pt;font-weight: bold;"> Exempt     </span><span style="font-family: Arial;font-size: 10.0pt;font-weight: bold;"> Non-Exempt</span></p><p style="margin: 0.0pt;text-align: center;"><span style="font-family: Arial;font-size: 10.0pt;font-weight: bold;"> </span></p></td></tr></tbody></table></div><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;font-weight: bold;"> </span></p><table cellspacing="0" cellpadding="0" style="border-collapse: collapse;margin-left: 0.0pt;"><tbody><tr><td style="padding-left: 4.9pt;padding-right: 4.9pt;vertical-align: top;width: 432.0pt;border: 1.0pt solid rgb(0,0,0);"><div style="clear: both;margin: 0.0pt;border: 0.75pt solid rgb(0,0,0);"><h2 style="background-color: rgb(224,224,224);font-weight: normal;margin: 0.0pt;padding-left: 4.0pt;padding-right: 4.0pt;padding-top: 1.0pt;"><span style="font-family: Arial;font-size: 12.0pt;font-weight: bold;text-decoration: underline;">SUMMARY DESCRIPTION</span></h2><p style="background-color: rgb(224,224,224);margin: 0.0pt;padding-bottom: 1.0pt;padding-left: 4.0pt;padding-right: 4.0pt;"></p></div><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;">We are seeking a highly motivated, energetic professional capable of working effectively in fast-paced environment to join our International Regulatory Affairs team. This position will be responsible for </span><span style="font-family: Arial;font-size: 12.0pt;">developing </span><span style="font-family: Arial;font-size: 12.0pt;">the strategy, preparation and execution o</span><span style="font-family: Arial;font-size: 12.0pt;">f regulatory submissions (marketing applications (MAs) and post-marketing maintenance) for </span><span style="font-family: Arial;font-size: 12.0pt;">BioMarin </span><span style="font-family: Arial;font-size: 12.0pt;">products, interfacing with the Japanese regulatory authorities (</span><span style="font-family: Arial;font-size: 12.0pt;">e.g</span><span style="font-family: Arial;font-size: 12.0pt;">.</span><span style="font-family: Arial;font-size: 12.0pt;"> </span><span style="font-family: Arial;font-size: 12.0pt;">MHLW</span><span style="font-family: Arial;font-size: 12.0pt;">, </span><span style="font-family: Arial;font-size: 12.0pt;">PMDA), and for providing insight and support for clinical development in Japan. </span><span style="font-family: Arial;font-size: 12.0pt;">This</span><span style="font-family: Arial;font-size: 12.0pt;"> </span><span style="font-family: Arial;font-size: 12.0pt;">position</span><span style="font-family: Arial;font-size: 12.0pt;"> is</span><span style="font-family: Arial;font-size: 12.0pt;"> </span><span style="font-family: Arial;font-size: 12.0pt;">based in the Tokyo office</span><span style="font-family: Arial;font-size: 12.0pt;">.</span></p></td></tr></tbody></table><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;font-weight: bold;"> </span></p><table cellspacing="0" cellpadding="0" style="border-collapse: collapse;margin-left: 0.0pt;"><tbody><tr><td style="background-color: rgb(224,224,224);padding-left: 4.9pt;padding-right: 4.9pt;vertical-align: top;width: 432.0pt;border-width: 1.0pt 1.0pt 0.75pt 1.0pt;border-color: rgb(0,0,0);border-style: solid;"><p style="margin: 0.0pt;"><span style="background-color: rgb(224,224,224);font-family: Arial;font-size: 12.0pt;font-weight: bold;text-decoration: underline;">RESPONSIBILITIES</span></p><p style="margin: 0.0pt;"></p></td></tr><tr><td style="padding-left: 4.9pt;padding-right: 4.9pt;vertical-align: top;width: 432.0pt;border-width: 0.75pt 1.0pt 1.0pt 1.0pt;border-color: rgb(0,0,0);border-style: solid;"><div style="border-top-color: rgb(228,237,243);border-top-width: 0.75pt;clear: both;margin: 0.0pt;"><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;">Develop Japanese Regulatory filing strategies and identify risks and potential gating factors. </span><span style="font-family: Arial;font-size: 12.0pt;">Play an active role in </span><span style="font-family: Arial;font-size: 12.0pt;">leading </span><span style="font-family: Arial;font-size: 12.0pt;">the </span><span style="font-family: Arial;font-size: 12.0pt;">strategic </span><span style="font-family: Arial;font-size: 12.0pt;">planning </span><span style="font-family: Arial;font-size: 12.0pt;">and preparation of complex submissions including but not limited to the following: JNDA</span><span style="font-family: Arial;font-size: 12.0pt;">/J</span><span style="font-family: Arial;font-size: 12.0pt;">s</span><span style="font-family: Arial;font-size: 12.0pt;">NDA</span><span style="font-family: Arial;font-size: 12.0pt;"> (content development, assembly of the dossier, submission through approval); post-marketing maintenance including </span><span style="font-family: Arial;font-size: 12.0pt;">re-examinations, </span><span style="font-family: Arial;font-size: 12.0pt;">JAN applications, </span><span style="font-family: Arial;font-size: 12.0pt;">expedited pathway applications </span><span style="font-family: Arial;font-size: 12.0pt;">and any other required submissions in Japan. Must ensure all submissions are prepared in accordance with J</span><span style="font-family: Arial;font-size: 12.0pt;">apanese </span><span style="font-family: Arial;font-size: 12.0pt;">regulations. </span><span style="font-family: Arial;font-size: 12.0pt;">Serve as primary liaison with the </span><span style="font-family: Arial;font-size: 12.0pt;">r</span><span style="font-family: Arial;font-size: 12.0pt;">egulatory authorities (e.g., MHLW</span><span style="font-family: Arial;font-size: 12.0pt;">, </span><span style="font-family: Arial;font-size: 12.0pt;">PMDA) and interface on behalf of BioMarin</span><span style="font-family: Arial;font-size: 12.0pt;"> to negotiate as needed to support plans for new drug registrations and activities for existing product licenses. Lead in preparation for and execution of </span><span style="font-family: Arial;font-size: 12.0pt;">a</span><span style="font-family: Arial;font-size: 12.0pt;">gency meetings.</span><br /><span style="font-family: Arial;font-size: 12.0pt;">Actively participate in multi-functional global team environment, and </span><span style="font-family: Arial;font-size: 12.0pt;">i</span><span style="font-family: Arial;font-size: 12.0pt;">nterface closely with U.S. and other global BioMarin offices to align on operational and strategic deliverables.</span></p><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;">Evaluate </span><span style="font-family: Arial;font-size: 12.0pt;">new and emerging </span><span style="font-family: Arial;font-size: 12.0pt;">regulations/guidance to advise BioMarin on the Japanese Regulatory environment and changes that could impact BioMarin’s products o</span><span style="font-family: Arial;font-size: 12.0pt;">r plans. </span></p></div></td></tr></tbody></table><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;font-weight: bold;"> </span></p><table cellspacing="0" cellpadding="0" style="border-collapse: collapse;margin-left: 0.0pt;"><tbody><tr><td style="background-color: rgb(224,224,224);padding-left: 4.9pt;padding-right: 4.9pt;vertical-align: top;width: 432.0pt;border-width: 1.0pt 1.0pt 0.75pt 1.0pt;border-color: rgb(0,0,0);border-style: solid;"><p style="margin: 0.0pt;"><span style="background-color: rgb(224,224,224);font-family: Arial;font-size: 12.0pt;font-weight: bold;text-decoration: underline;">EDUCATION</span></p><p style="margin: 0.0pt;"></p></td></tr><tr><td style="padding-left: 4.9pt;padding-right: 4.9pt;vertical-align: top;width: 432.0pt;border-width: 0.75pt 1.0pt 1.0pt 1.0pt;border-color: rgb(0,0,0);border-style: solid;"><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;">A bachelor of science degree in</span><span style="font-family: Arial;font-size: 12.0pt;"> </span><span style="font-family: Arial;font-size: 12.0pt;">life science</span><span style="font-family: Arial;font-size: 12.0pt;">.</span></p><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;">Qualified Pharmacist</span><span style="font-family: Arial;font-size: 12.0pt;"> </span><span style="font-family: Arial;font-size: 12.0pt;">is </span><span style="font-family: Arial;font-size: 12.0pt;">a plus</span><span style="font-family: Arial;font-size: 12.0pt;">.</span><span style="font-family: Arial;font-size: 11.0pt;">  </span></p><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;">Fluent in Japanese and English.</span></p></td></tr></tbody></table><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;font-weight: bold;"> </span></p><table cellspacing="0" cellpadding="0" style="border-collapse: collapse;margin-left: 0.0pt;"><tbody><tr><td style="background-color: rgb(224,224,224);padding-left: 4.9pt;padding-right: 4.9pt;vertical-align: top;width: 432.0pt;border-width: 1.0pt 1.0pt 0.75pt 1.0pt;border-color: rgb(0,0,0);border-style: solid;"><p style="margin: 0.0pt;"><span style="background-color: rgb(224,224,224);font-family: Arial;font-size: 12.0pt;font-weight: bold;text-decoration: underline;">EXPERIENCE</span></p><p style="margin: 0.0pt;"></p></td></tr><tr><td style="padding-left: 4.9pt;padding-right: 4.9pt;vertical-align: top;width: 432.0pt;border-width: 0.75pt 1.0pt 1.0pt 1.0pt;border-color: rgb(0,0,0);border-style: solid;"><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;">Mi</span><span style="font-family: Arial;font-size: 12.0pt;">nimum of </span><span style="font-family: Arial;font-size: 12.0pt;">ten years of industry experience with at least </span><span style="font-family: Arial;font-size: 12.0pt;">si</span><span style="font-family: Arial;font-size: 12.0pt;">x</span><span style="font-family: Arial;font-size: 12.0pt;"> </span><span style="font-family: Arial;font-size: 12.0pt;">years of</span><span style="font-family: Arial;font-size: 12.0pt;"> </span><span style="font-family: Arial;font-size: 12.0pt;">experience in Regulatory Affairs </span><span style="font-family: Arial;font-size: 12.0pt;">in the biotechnology or pharmaceutical industries, including </span><span style="font-family: Arial;font-size: 12.0pt;">good</span><span style="font-family: Arial;font-size: 12.0pt;"> </span><span style="font-family: Arial;font-size: 12.0pt;">knowledge and understanding of the </span><span style="font-family: Arial;font-size: 12.0pt;">Japanese</span><span style="font-family: Arial;font-size: 12.0pt;"> regulatory environment.  </span></p><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;">Proven track record for preparing, submitting, and gaining approvals for JNDAs. </span></p><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;">The candidate is expected to have a thorough understanding of relevant drug development</span><span style="font-family: Arial;font-size: 12.0pt;"> </span><span style="font-family: Arial;font-size: 12.0pt;">regulations and guidelines and to have outstanding interpersonal and communication (written and verbal) skills and effective task planning and coordination abilities. </span></p><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;">Experience as clinical scientist </span><span style="font-family: Arial;font-size: 12.0pt;">and/</span><span style="font-family: Arial;font-size: 12.0pt;">or in-depth understanding of clinical </span><span style="font-family: Arial;font-size: 12.0pt;">development</span><span style="font-family: Arial;font-size: 12.0pt;"> as a regulatory st</span><span style="font-family: Arial;font-size: 12.0pt;">rategist is </span><span style="font-family: Arial;font-size: 12.0pt;">highly </span><span style="font-family: Arial;font-size: 12.0pt;">desired.</span></p><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;">Proficiency with computer and standard software programs is required. </span><span style="font-family: Arial;font-size: 12.0pt;">The c</span><span style="font-family: Arial;font-size: 12.0pt;">andidate </span><span style="font-family: Arial;font-size: 12.0pt;">is expected t</span><span style="font-family: Arial;font-size: 12.0pt;">o </span><span style="font-family: Arial;font-size: 12.0pt;">be flu</span><span style="font-family: Arial;font-size: 12.0pt;">ent in English, both verbal and written (technical). </span><span style="font-family: Arial;font-size: 12.0pt;"> Strong collaborative skills are needed as this position requires close working relationships with stakeholders both inside and outside of the compa</span><span style="font-family: Arial;font-size: 12.0pt;">ny.  </span><span style="font-family: Arial;font-size: 12.0pt;">Good</span><span style="font-family: Arial;font-size: 12.0pt;"> </span><span style="font-family: Arial;font-size: 12.0pt;">verbal, written and presentation skills are also required.  </span></p></td></tr></tbody></table><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;font-weight: bold;"> </span></p><table cellspacing="0" cellpadding="0" style="border-collapse: collapse;margin-left: 0.0pt;width: 94.1083%;height: 168.344px;"><tbody><tr style="height: 67.1719px;"><td style="background-color: rgb(224,224,224);padding-left: 4.9pt;padding-right: 4.9pt;vertical-align: top;width: 0.0%;border-width: 1.0pt 1.0pt 0.75pt;border-color: rgb(0,0,0);border-style: solid;height: 67.1719px;"><p style="margin: 0.0pt;"><span style="background-color: rgb(224,224,224);font-family: Arial;font-size: 12.0pt;font-weight: bold;text-decoration: underline;">CONTACTS</span></p><p style="margin: 0.0pt;"></p></td></tr><tr style="height: 101.172px;"><td style="padding-left: 4.9pt;padding-right: 4.9pt;vertical-align: top;width: 0.0%;border-width: 0.75pt 1.0pt 1.0pt;border-color: rgb(0,0,0);border-style: solid;height: 101.172px;"><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;">The candidate must interact with </span><span style="font-family: Arial;font-size: 12.0pt;">Japan</span><span style="font-family: Arial;font-size: 12.0pt;"> </span><span style="font-family: Arial;font-size: 12.0pt;">team members, </span><span style="font-family: Arial;font-size: 12.0pt;">International team members, and colleagues based in the global company headquarters. </span></p><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;">BioMarin is Headquartered in California.</span></p><p style="line-height: 12.0pt;margin: 0.0pt 0.0pt 14.25pt;"><span style="font-family: Arial;font-size: 12.0pt;">The position will report directly to the </span><span style="font-family: Arial;font-size: 12.0pt;">Head of APAC</span><span style="font-family: Arial;font-size: 12.0pt;"> Regulatory Affairs based in </span><span style="font-family: Arial;font-size: 12.0pt;">Tokyo.</span></p></td></tr></tbody></table><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;font-weight: bold;"> </span></p><table cellspacing="0" cellpadding="0" style="border-collapse: collapse;margin-left: 0.0pt;"><tbody><tr><td style="background-color: rgb(224,224,224);padding-left: 4.9pt;padding-right: 4.9pt;vertical-align: top;width: 432.0pt;border-width: 1.0pt 1.0pt 0.75pt 1.0pt;border-color: rgb(0,0,0);border-style: solid;"><p style="margin: 0.0pt;"><span style="background-color: rgb(224,224,224);font-family: Arial;font-size: 12.0pt;font-weight: bold;text-decoration: underline;">SUPERVISOR RESPONSIBILITY</span></p><p style="margin: 0.0pt;"></p></td></tr><tr><td style="padding-left: 4.9pt;padding-right: 4.9pt;vertical-align: top;width: 432.0pt;border-width: 0.75pt 1.0pt 1.0pt 1.0pt;border-color: rgb(0,0,0);border-style: solid;"><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 11.0pt;">No direct reports.</span></p></td></tr></tbody></table><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;font-weight: bold;"> </span></p><p style="margin: 0.0pt;"><span style="font-family: Arial;font-size: 12.0pt;font-weight: bold;"> </span></p></div>