RAアソシエイトディレクター

Job Details

<職務内容>

・Preparation of regulatory strategies for submission and approval of new product applications (MAA/NDA), management of submission teams, dossier compilation, responses to questions and negotiations with authorities
・Regulatory maintenance of existing marketing authorizations for global products, including label and PIL management and regulatory compliance
・Scientific advice, and other health authority meetings
・Submission and approval of clinical trial applications (CTA) and IND’s
・Project team support, actively participating and representing GRAD in teams for development of new products/product extensions and drafting related regulatory strategies
・Interdepartmental co-operation with active participation in collaborative meetings, e.g. lectures
・Regulatory leadership, lead and coordinate regulatory submissions and related projects, motivate colleagues to ensure timely deliverables and high quality

<応募要件>

・Life Science or Pharmacy degree
・2- 5 years experiences from Regulatory area
・Understanding of GLP, GCP and GMP

<就業時間>就業時間 :9:00 ~ 17:30 / 所定労働時間 07時間30分 フレックスタイム制 有 / コアタイム 有 10:30 ~ 16:00

<会社概要>

グローバルに展開する研究開発型の製薬メーカーになります。欧州系メーカーのため充実した報酬システムと福利厚生、昇進機会があるのが特徴です。

<注目ポイント>

新しいR&Dヘッドのもと新組織下の新しいチーム編成となります。再生医療領域をはじめ今後ますます増えるパイプラインを支えていただく重要なポジションです。非常に柔軟な企業文化があり、働きやすい環境が整っているのも特徴です。ご興味がございましたら、是非お早めにお問い合わせください!

Job application

Apex delivers strong profile and highly skilled candidates that match the job description requirements. Their candidate know how, network and experience helped us to initiate contact and integrate the candidate into our company. We are very happy with the candidate selected by Apex. K.K. consulting service. Thank you for the professional recruitment consulting service throughout the selection and follow up. We really appreciated it and strongly recommend Apex.

APAC Head of Supply Chain

Global Healthcare Company