Associate Director, Regulatory Operation, Regulatory Affairs

で見つかりました。 Talent JP C2 - 2週間前

Tokyo Alexion Pharmaceuticals Full time

Position Summary

The Associate Submission Director is accountable for managing the major and non-routine submission activities for Alexion's portfolio. The Associate Submission Director designs and executes high quality global submission plans, ensuring Alexion delivers compliant submissions to global health authorities within required timeframes. The Associate Submission Director provides technical expertise to cross-functional submission project teams, to promote and bring excellence in planning, preparation and delivery of regulatory submissions. The Associate Submission Director will act as the primary point of contact for project and/or submission teams when significant planning effort and oversight is required. The Associate Submission Director will also lead in activities related to setting standards, best practices, developing new procedures and work instructions, and lessons learned dissemination. It is also expected that Associate Submission Director will be involved in publishing and archiving activities and mentoring junior members of the group. Oversees and monitors the overall archiving activities in the GRO Group.

薬事オペレーションのアソシエイトディレクター(AD)は、Alexion のポートフォリオの主要な、ルーティンではない承認申請業務を管理する責任を負う。 ADは、CTD及び電子データについて高品質の提出計画を設計・作成し、世界の規制当局に対して、要求された期間内に、規制に準拠した申請(eCTD、電子データ他)を確実に提出する。 ADは、クロスファンクショナルな申請プロジェクト チームに技術的な専門知識を提供し、申請の計画、準備、提出供を促進し、優れた成果をもたらす。 ADは、プランの遂行に多大な努力や監視が必要な場合には、プロジェクト チームおよび/または申請チームの主な連絡窓口として役割を果たす。 ADは、スタンダードの設定、ベストプラクティス、新しい手順やWork instructionの開発、Lessons and Learndの普及活動をリードする。 パブリッシング及びアーカイブ活動、グループの後輩メンバーの指導に携わることが期待される。 Global Regulatory GROperations グループのアーカイブ活動全体に携わり、ローカルにて推進・実行する。

Principal Responsibilities

With the increased pipeline and advanced phases of several programs the regulatory submission and operations workload has increased dramatically.

With a having global regulatory information management system, it is essential that Japan as well uses this system, for tracking registrations, commitments, and archive electronic submissions.

  • Lead electronic submissions, including the new data requirements, with the Japanese e-sub vendor, and the Global reg ops team.
  • Manages and tracks all regulatory data in the RIM system.
  • Prepare the CDISC submission working with Global CDISC team and APJ-Data Management member.
  • Make eCTD with using external venders
  • Submit electronic JNDA data and dossiers through GATE WAY to PMDA
  • Manage to archive Japanese Regulatory dossiers by aligning with Global Regulatory Operation team
  • Provide trainings based on Global SOPs regarding Regulatory Operation
  • Negotiates with subcontractors and external parties about pharmaceutical affairs issues.
  • Get enagaged in the Submission sub-team according to scope of discussion.

    • パイプラインが増加し、かつ、プログラムが進捗したことにより、承認申請とその作業負荷が大幅に増加した。また、グローバルの薬事情報管理システムを用いて日本の薬事情報の登録、コミットメントのフォローアップ、各種申請の電子的アーカイブすることが不可欠となった。

  • ベンダーおよびGlobal Regulatory Operation teamと協力して、最新のデータ要件(CTD V4.0等)を踏まえ、eCTD 及び申請電子データの提出をリードする
  • グローバル CDISC チームおよび APJ-Data Management メンバーと協力して 申請電子データ(CDISC)提出を準備する。
  • 外部ベンダーを利用してeCTDを作成する。
  • 申請電子データ及びeCTD、その他関係書類を GATE WAY 経由で PMDA に提出する。
  • RIM システム内のすべての薬事データを管理およびトラックする。
  • Global Regulatory Operation Teamと連携して、日本の規制当局関係書類のアーカイブを管理する。
  • 薬事オペレーションに関するグローバルSOPに基づき、研修を実施する。
  • 薬事オペレーション関連の業務委託先や外部関係者と交渉し、契約を締結する。
  • 申請チームに参加する。

    • Qualifications

    A minimum of 7 years of experience in regulatory affairs/operations within the pharmaceutical industry (or IT industries).

    Japanese fluent level, English bussiness level.

    Strong verbal and written communication and presentation skills. A superb training skill is a plus.

    Strong interpersonal skills and ability to work effectively and build relationships with cross-functional teams.

    Self-motivated and results-oriented with high energy drive to mentor junior members of the group

    Highly knowledgeable in CTD/eCTD structure and requirements and a solid understanding of submission requirements for global submission types (e.g. IND, NDA, CTN, PSUR etc.).

    Solid experience in publishing and compilation of eCTD submissions for US and EU filings is required and experience publishing electronic submissions in other regions is desirable.

  • 製薬業界 (または IT 業界) での薬事/薬事オペレーション業務について7 年以上の経験を有する。
  • 日本語:Nativeレベル、英語:ビジネスレベル(日常的に使用します)
  • 口頭および書面による優れたコミュニケーション能力とプレゼンテーション能力。優れたトレーニングスキルもプラス
  • 優れた対人スキル、効果的に働き、部門を越えたチームとの関係を構築する能力。
  • 自発的で結果志向で、グループの後輩メンバーを指導するための高いエネルギー意欲を​​持つ
  • CTD/eCTD の構造と要件に関する知識が豊富で、グローバルなの各種申請 (例: IND、NDA、CTN、PSUR など) の提出要件をしっかりと理解している。
  • 米国および EU での申請用eCTDのパブリッシングと編集における経験がある。その他の地域での電子提出物のパブリッシング経験が望ましい。

    • Date Posted

    20-2月-2024

    Closing Date

    Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact . Alexion participates in E-Verify.

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