At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Product Submissions and Registration **Job Category:** Professional **All Job Posting Locations:** Chiyoda, Tokyo, Japan **Job Description:** **JOB** **SUMMARY** Under the supervision of their supervisor: + DevelopJapanesepackageinserts(JapanesePI)basedonJapanesetargetlabel + RunJapanLabelingcommitteeprocesstodeveloplabelingpositionsformarketedproductissues + CollaboratewithGlobalLabelingand/orCDToncreation/revisionofJapanesePIproactively + Maintain someJapanesePIinpost-approvalenvironmentand negotiateJapaneselabelingofMarketedproducts with HA **KEY** **RESPONSIBILITIES** **Development** **J-** **PI** + Participatesindevelopmentoflabeling negotiationJapanese strategiesanddevelopmentofsupporting documentation for Japanese labeling + DevelopJapanesePIfromJapaneseTargetLabel + UpdateJapanesePIbasedonupdatedCCDSandnewdata + InterfacewithtrackingfunctiontoensurethatchangesarebeingtrackedandadviseonJapaneselabelaudit + RuntheJapanLabelingWorkingGroupprocessandparticipateinthesegroups **Labeling** **Committee** + Run JapanLabelingcommittee processto develop Japaneselabelingpositionsforboth development andmarketed productissues + ExplainlabelingpositiononproposedlabelingattheJapanLabelingCommittee + PreparefinalproposedJapanesePIforreviewbyLabelingWorkingGroupandLabelingCommittee **Relationship** **with** **Global** **Team** + ServeasasupportmemberoftheglobalLabelingWorkingGroupandprovidesinput onproposed updatestothe CCDS/USPI/SmPC + ReceiveinformationonCCDSfromGlobalLabelinganddisseminateittorelevantpeopleinJANSSENJAPAN + CommunicatewithGlobalLabelingand/orCDToncreation/revisionofJapanesePI + ShareinformationwithGlobalLabelingonUS/EU/Japanlabelingandactasawindowtoit + ProvidesupportinpreparingresponsestoCallforInformation inpreparationofPSURsregardingJapaneseinput (Approval information: Indication, Dosage and Administration etc). **Post** **approval** **maintenance** + Maintain Japanese PI in post-approval environment + Revise Japanese PI and provide input on implementation timelines as necessary + Provide labeling support necessary to defend the company labeling position in Japan when issues arise + Team with Japanese Labeling Therapeutic area representatives and collaborate with partners including Health Authorities, Manufacturing, Regulatory Operations, and Regulatory Affairs etc in Japan. **Interactions with** **HA** + Negotiate Japanese labeling of post-approval products with HA (ensure alignment with global strategy) as appropriate + Review Japanese PI in preparation for meeting with Health Authorities **Print Labeling and** **others** + Execute the technical aspects of labeling process (e.g., partner with Japan Submission Operations to prepare labeling submissions, and with Graphic Services to develop artwork for implementation in packaging and website display) + Prepare Japan unique explanatory documents called "Kaisetsusho" which explains rationale for "Precautions for Use" included in new drugs' J-PI. + Ensure effective quality control of labels **REQUIREMENTS** **Experience/Knowledge** + A minimum of 3 years of pharmaceutical industry experience (clinical development, safety, regulatoryaffaris) and/orexperienceassociatedwithproductlabeling/labelingregulationsis required. **Skills/Capabilities** + GoodverbalandwrittencommunicationskillsinJapanese/Englishisrequired. TOEICscore:over700 **Qualification/Certificate** + Aminimum ofBachelordegreeinascientific discipline,especiallypharmaceuticalscience,is preferred. **＜For Internal Applicants＞** •Based on your experience and interview evaluation, the position title and level may vary. •If you are Japan employee, please read “Internal Application Guideline” in Ask GS. Especially if you are less than 18 months in your current role, you are required to obtain application approval from your current manager as well as your respective BUHR. If you are Japan’s employee, you are not able to apply for multiple positions at once. •For Employee Referral Program (ERP), please read and understand the details of the “Internal Referral Overview” on the Ask GS and you have made a compliant referral. **Required Skills:** **Preferred Skills:** Analytical Reasoning, Brand Research, Business Behavior, Design Thinking, Detail-Oriented, Industry Analysis, Market Research, Package and Labeling Regulations, Problem Solving, Process Oriented, Product Packaging Design, Project Management, Project Support, Proof Reading Software, Quality Assurance (QA), Regulatory Affairs Management, Regulatory Compliance, Risk Assessments, Safety-Oriented