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 Affairs **Job Category:** Professional **All Job Posting Locations:** Chiyoda, Tokyo, Japan **Job Description:** **JOB** **SUMMARY:** + Managementof licensesfor Marketing AuthorizationHolder (MAH) + ManagementofForeignManufacturerAccreditation(FMA) + Managementof periodic Good Manufacturing Practice (GMP)inspection + Supportsall regulatoryactivitiesassociatedwiththe registrationandmaintenanceofapproveddrugproducts **KEY** **RESPONSIBILITIES:** **Manufacturing** **Authorization Holder (MAH)** + Manageandmaintain the Open Approval system lists for marketed products. + Conductsproceduresfor newregistration/renewal/changeofMAH. **Foreign** **Manufacturer** **Accreditation** **(FMA)** + Manageandmaintainthe listsofFMA. + Conduct procedures for new registration/renewal/change of FMA. + Conduct an annual survey to confirm changes. **Periodic** **GMP** **inspection** + Managethe schedule of periodic GMP inspection. + Preparethe material of periodic GMP inspectionwith the Commercial Quality (CQ)membersandhandle inquiriesfromPMDA. **Regulatory Support for marketed products** + Handle life cycle management on approved matters and Post Marketing Commitment (PMC). + Providethe appropriateadvice regarding theregulatoryactivities + CommunicatewithHealthAuthorityforthe resolutionof a regulatoryissue **Others** + Verificationof labelsonpackages: Confirmthat labelsonpackagesare designed in accordance withregulations. + Verificationofmaterials:Confirmthatmaterialsare created in accordance withregulationsandpromotioncodes. + Handle requestsforinformationdisclosure:Confirmthatappropriate descriptionsare maskedandcontactwithregulators. + Support JCoT activities for post-marketing regulatory activities as a JCoT member **REQUIREMENTS:** **Experience/Knowledge** + ThoroughknowledgeofGQP-relatedactivitiesaswellas1+yearsworking experienceoftherelevantactivitiesoranequivalent carrier. **Skills/Capabilities** + Solidcommunicationandcomputerskills are required. + Mustbeproficientat speakingandwritingbothJapanese andEnglish,withgoodwritten andoral communication skills. + TOEIC score: over 700 **〈 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, Business Behavior, Business Writing, Communication, Confidentiality, Data Reporting, Detail-Oriented, Legal Support, Medicines and Device Development and Regulation, Problem Solving, Product Licensing, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Teamwork