Job title:
Senior Specialist, Regulatory Affairs
【業務内容】
Ensures rapid and timely approvals for respective product lines by plans on all product registration, manage all product registrations' preparation and documentation.
各製品ラインの迅速かつタイムリーな承認を確保するために、すべての製品登録に関する計画を立て、登録準備および関連書類の管理を行います。
規制当局の担当者と連携し、保留中の登録の承認を迅速に進めるとともに、製品書類に関する質問に対応します。
また、経営陣に対して、製品登録の進捗状況や政府機関からの新たな規制に関する定期的な報告を行います。
Provides input on regulatory related issues associated with compliance and achieving the business plan.
Prioritize and plan on product registration for his/her respective product.
Preparing, coordinating and submitting regulatory applications to the local health authority.
Maintain an active knowledge of the status of pending approvals and shepherd registrations through the approval process.
Provide the management team with regular updates on product registration.
Establish and implement plans to maintain a trusted relationship with the local health authorities through regular meetings, discussions, training and education.
Lobby the local health authorities using constructive/scientific challenges to regulations. This should include guidance on alternative solutions to country regulatory needs.Supports tender operations by timely supply of accurate regulatory.
Establishes relationships with local medical device industry groups and works with industry peers to lobby the Competent Authorities in matters of regulatory issues and to influence local policies.
Establish and maintain a good working relationship with regional RA peers to gain positive & timely support for document preparation.
Serves as regulatory consultant to marketing team and government regulatory agencies.Complete the mandatory Quality training subject to the defined timeline. And ensure compliance with internal Quality system and policy.
コンプライアンスおよび事業計画の達成に関連する規制関連の課題について、意見を提供します。
担当製品の登録を優先順位付けし、計画を立てます。
規制当局への申請書類の準備、調整、提出を行います。
承認待ちの状況を常に把握し、登録がスムーズに進むように支援します。
製品登録の進捗状況について、経営陣に定期的に報告します。
規制当局との信頼関係を維持するため、定期的な会議、ディスカッション、トレーニング、教育を通じて関係構築・維持の計画を立て、実行します。
規制に対して建設的かつ科学的な視点から異議を唱え、代替案を提示することで、規制当局への働きかけを行います。
入札業務を支援するため、正確な規制情報をタイムリーに提供します。
医療機器業界団体と関係を築き、業界の仲間と協力して規制当局に働きかけ、現地の政策に影響を与えます。
文書作成において、地域のRA(Regulatory Affairs)担当者と良好な関係を築き、迅速かつ前向きなサポートを得られるようにします。
マーケティングチームおよび政府の規制当局に対して、規制に関するコンサルタントとしての役割を果たします。
定められた期限内に必須の品質トレーニングを完了し、社内の品質システムおよびポリシーを遵守します。
【必須経験】
医療機器クラスIII以上での薬事経験 2年以上
英語:
ビジネスレベル
既存の戦略やプロセスに固執することなく Proactive に自ら考え立案し交渉できる。
事業部、事業部、PMDA、グローバルとの難しい交渉を単独でマネージできる、グローバルとの難しい交渉を単独でマネージできる。
すべての情報が揃わなくても動き始めるAgilityがある。
変化を前向きに解釈し前に進む。
臨機応変に変化を捉える。
【Want要件】
薬事申請経験者歓迎
【勤務地】
本社(東京都中野区)
※ハイブリッドワーク
Boston Scienftific
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