掲載期間:21/10/08~22/04/07 求人管理No.017715

外資製薬メーカー

Senior Scientist, Regulatory CMC Japan

  • 年間休日120日以上
  • フレックス勤務
  • 転勤なし
  • 社宅・住宅手当有
  • 退職金制度有
  • 英語を活かす

募集要項

大手外資製薬メーカーの子会社にてCMC薬事の求人です。

仕事内容

Reporting to the CMC Principal Scientist, Regulatory CMC Japan, the successful candidate will be responsible for assessment of changes for regulatory impact, development of Japan CMC strategy, preparation of CMC documentation and execution of regional post-approval CMC supplements and new product registrations for the entire company portfolio of small molecule, biologic and biosimilars, serving as a link between Country Regulatory Affairs (CRA) team requirements and global CMC strategy to ensure right first-time submissions to Health Authorities. He/she will work closely with CMC Product Leads to ensure that company's key CMC projects are successfully prosecuted in Japan.


【Responsibilities】
The incumbent will be accountable for implementing CMC strategy for Japan for post-approval CMC supplements and new product submissions with a focus on achieving right-first-time submissions, including the following activities:

・For assigned product portfolio, develop robust local (Japan) CMC regulatory strategies for new marketing applications, Scientific Advice and post-approval changes, as appropriate.
・Working collaboratively with Global CMC Regulatory Affairs Product Leads, the incumbent will ensure right first-time submissions, high approval rates, on target launches and successful implementation to maintain patient supplies throughout the lifecycle.
・Ensure that the Japan CMC regulatory strategy is aligned with the global regulatory strategy, Franchise portfolio, commercial and operational strategies and issues impacting product approval, launch or patient supplies will be appropriately escalated to CMC Regulatory Affairs Management.
・Support Country RA affiliate interactions with their local Regulatory Agencies to facilitate Scientific Advice and the prompt review and approval of submissions (as CMC content subject matter expert).
・Act as Regulatory CMC SME in Japan post approval requirements, ensure awareness of local regulatory policy trends and maintain/update the regulatory intelligence repository for Japan, including communicating proactively with Global CMC Product Leads on local registration requirements, new legislation and guidance and providing timely update of the CMC change management systems to support right first time submissions.
・Ensure high quality and timely responses to Regulatory Agency questions and fulfillment of regulatory commitments to Regulatory Agency deadlines.
・Support product compliance by ensuring local registrations and lifecycle management align with product manufacturing details.
・Drive continuous process improvement activities within the organization and participate in forums to ensure efficient processes and best practice.
・Influence CMC initiatives by internal and external engagement including trade associations and regulators to pursue priority advocacy plans impacting the business.

応募条件
【必須事項】
・大学卒以上(化学、薬学、生物学または科学)
・製薬業界にて規制関連または実務経験4年以上
・ビジネスレベルの英語力
【歓迎経験】
【免許・資格】
【勤務開始日】
応相談
学歴
大学卒以上
雇用形態
正社員
試用期間
3ヶ月

契約期間
勤務地
東京
転勤の有無
転勤なし
受動喫煙防止措置
敷地内禁煙(喫煙場所なし)
勤務時間
フレックス制度 コアタイムなし
休憩時間
60分
時間外労働
勤務開始日
応相談
休日休暇
(1)毎日曜日(2)毎土曜日(3)国民の祝日及び国民の休日(4)創立記念日(10月1日)(5)年末年始(自12月30日至1月4日)

有給休暇: 入社半年経過時点20日、初年度は入社する月に応じて付与
年収・給与
経験により応相談
諸手当
昇給
賞与
採用人数
1名 
待遇・福利厚生
【待遇】
健康保険、厚生年金、総合福祉団体定期保険、長期障害所得補償保険、労災補償
借上げ社宅制度 など
【福利厚生】
選考プロセス
1)書類選考
2)一次面接
3)最終面接

外資製薬メーカー

Senior Scientist, Regulatory CMC Japan

  • 年間休日120日以上
  • フレックス勤務
  • 転勤なし
  • 社宅・住宅手当有
  • 退職金制度有
  • 英語を活かす

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仕事内容:
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年収:
経験により応相談
勤務地:
東京