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 atJob Function
Regulatory Affairs Group
Job Sub Function
Regulatory Affairs
Job Category
Professional
All Job Posting Locations:
Chiyoda, Tokyo, Japan
Job Description
目的:
一般外科領域製品(外科用縫合糸、組織用接着材等)の薬事承認の維持管理。(担当領域は、経験や希望に応じて調整する場合あり。)
役割:
担当製品群の薬事申請及び承認等取得、変更管理や安定供給を含む薬事対応業務全般の遂行。
担当製品の薬事戦略立案から、薬事申請(承認申請、認証申請、届出)・承認等取得、
それに必要な社内外のステークホルダーとの関係構築、対外折衝、プロジェクトマネジメント
変更管理に至る薬事対応業務全般(行政相談を含む)の推進及び実施
社内規定に基づく広告審査業務及び関連するステークホルダーからの問い合わせ対応
社内関係部門との調整やコンプライアンスに関わる業務の遂行、部内メンバーの育成・指導
その他の業務
部門の優先課題など、社内の組織的活動への参加及び貢献
関連する業界団体活動への参画及び意見募集への貢献
必要な最低学歴:
学士以上の学位(学部問わず)
関連経験の必要年数:
医薬品又は医療機器業界における3年以上の薬事業務の経験
または、医薬品又は医療機器業界における5年以上の研究開発(R&D)又は品質保証業務経験を有し、かつ国内の薬事法令要求事項に対応した経験を有する
必要な知識、スキル、能力:
ロジカルシンキング及びロジカルライティングスキル
海外製造元の作成した設計開発文書(英語)を読解、理解することができ、また海外の社内関係者と口頭及び文章でコミュニケーションできる程度の英語力(
TOEIC:
700以上)
関係者と協議し、主体的に問題解決を推進できるコミュニケーション能力及びプロジェクトマネジメントスキル
・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.
・Once you move to 1st interview stage, please make sure to inform to your current manager.
・For Employee Referral Program (ERP), please read and understand the details of "Employee Referral Program" in Ask GS and make a compliant referral.
・応募の際はAskGS内の社内公募ガイドラインをご一読いただき、応募ください。18か月未満の方は応募前に上長及び担当BUHRの許可を取ってから応募ください。複数同時応募不可になります。
・在籍期間に関わらず、書類選考を通して1次面接に進んだ場合は、社内公募に応募し選考に進むことを上司に報告してください。
・社内紹介を行う場合は、ASK GS上の"Employee Referral Program"の詳細を理解した上で、コンプライアンスを守って紹介したものとみなします。
Required Skills
Preferred Skills:
Analytical Reasoning, Business Behavior, Business Writing, Collaborating, Communication, Confidentiality, Data Reporting, Data Savvy, Detail-Oriented, Execution Focus, Legal Support, Medicines and Device Development and Regulation, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments
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