薬事部 海外cmc薬事室（アジア・欧米cmc薬事担当）

＜業務内容＞ ヨーロッパ・北米および日本以外のアジア・アラブ諸国等における導入・開発段階（初期～後期）から承認申請・承認取得・承認後変更申請に係るCMC薬事業務全般 ・CMC薬事戦略策定 ・CMC申請資料及び製造所登録／更新資料の作成と規制当局からの照会事項対応（現地作成の品質資料のレビューを含む） ・承認後変更に関する薬事影響評価・承認後変更申請対応 ・導入品評価 ＜必須要件＞ ・医薬品のCMC薬事又はCMC関連業務（原薬・製剤研究、生産、品質管理、品質保証等も含む）の経験：5年以上 ・自発的・プロアクティブであること/コミュニケーション能力/交渉力 ＜語学力＞ ・英語力（CEFR B2以上）を有する方 ＜歓迎要件＞ ・ヨーロッパ・北米・アジア関連業務経験又はプロジェクトマネージメント業務経験 ＜求める人物像＞ ・多様な価値観やバックグラウンドを尊重し、インクルーシブな職場づくりに貢献できる方 ・チームワークを重視し、関係者と良好なコミュニケーションを図りながら協働できる方 ・高い目標意識を持ち、主体的に行動できる方 ・分析的思考のできる方 ＜勤務地＞ 東京、大阪、徳島 Competencies Accountability for Results

• Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. Strategic Thinking & Problem Solving
• Make decisions considering the long-term impact to customers, patients, employees, and the business. Patient & Customer Centricity
• Maintain an ongoing focus on the needs of our customers and/or key stakeholders. Impactful Communication
• Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. Respectful Collaboration
• Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals. Empowered Development
• Play an active role in professional development as a business imperative. Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka . Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer . All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic . If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability . You can request reasonable accommodations by contacting Accommodation Request . Statement Regarding Job Recruiting Fraud Scams At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., a nd Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.