Title:  Assistant Manager, Regulatory Affairs

Job Summary

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General Responsibilities

化学品、化粧品原料、医薬品原料輸出入に関わる社内管理業務。EU REACH対応のサポート
【具体的には】
・輸出入に関わる化学品、化粧品原料、医薬品中間体の管理、法令確認業務
・EUのREACH対応のため、国内顧客と弊社EU担当者との調整、確認業務
・SDS作成、ラベル作成など付随する業務
・化審法に基づく少量新規、低生産、毒劇物等の当局への申請、輸入数量報告業務
※薬機法については入社後に研修もいたします。

In-house management operations related to the import and export of chemicals, cosmetic raw materials, and pharmaceutical raw materials. Support for EU REACH compliance
[Assignments in detail]
・Management and legal check of chemicals, cosmetic raw materials, and pharmaceutical intermediates related to import and export
・Coordination and legal check work between domestic customers and our counterparts in DKSH EU in order to comply with EU REACH
・Administrative works such as SDS creation and label creation
・Applications to authorities for new small quantities, low production, poisonous and deleterious substances, etc. based on the Chemical Substances Control Law, and reporting of import quantities
*The training programs regarding Pharmaceutical and Medical Device Law will be provided after joining the company.

Functional Skills and Knowledge

【必須要件】中級レベルの英語力をお持ちの方で下記に該当する方
・化審法、安衛法など化学物質管理・申請に関わる経験
・医薬品、化粧品等、薬機法に関わる知見
・基本的なPCスキル
・コミュニケーション能力の高い方

【歓迎要件】
・EU REACHに関する知見
(弊社から直接EUへの申請等は行いませんが、EU担当者と国内製造元との調整等の業務が発生することがあるため）

[Must-have Requirements] Those who have intermediate level English proficiency and meet the following requirements:
・Experience related to chemical substance management and application, such as the Chemical Substance Control Law and the Safety and Health Law.
・Knowledge related to pharmaceuticals, cosmetics, etc., and the Pharmaceutical and Medical Devices Act
・Basic PC skills
・Those with good communication skills

[Nicer-to-have requirements]
・Knowledge regarding EU REACH
(Although we do not directly apply the documents for the EU, there may be some works such as coordination between the person in DKSH EU and domestic manufacturers.)
 

Education

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