CMC薬事（神戸勤務）

求人詳細

This position is responsible, as a CMC Regulatory Science Expert, for writing and reviewing CMC relevant documents as well as assessing risks on clinical trials and future submission in Japan for all projects (New Molecular Entity) in accordance to all applicable guidelines and regulations (ICH, cGMP, SOPs, etc.) as well as in collaboration and coordination with XXX partners.


Accountabilities
1. Author and review the CMC relevant documents for regulatory submission (e.g. CTD, Investigators Brochure, etc) in Japan in accordance to all applicable guidelines and regulations (ICH, cGMP, SOPs, etc.)
Related Performance Indicators
-Author and review the Common Technical Document (CTD) and I.B.for Japan in quality sections in alignment with global documents.
-Review the key CMC documents in the department
-Interact with global/local regulatory affairs and R&D team on content and format of CMC documents

2. Contribute the project team from the CMC aspects in preparing any clinical study plans and regulatory relevant documents in accordance to all applicable guidelines and regulations (ICH, cGMP, SOPs, etc.) in view of future submission in Japan
Related Performance Indicators
-Proactively assess risks on future submission in Japan for all projects in late stage development
-Consult the project team to prepare regulatory relevant documents as well as development strategy in Japan
-Provide the project team with guidance in preparing any study plans in a way to enable successful clinical trials and regulatory submission
-Contribute to establishing strategies of proactive response to the health authorities in alignment with global documents.

3. Interface to regulatory agencies (e.g., PMDA) based on the global strategy
Related Performance Indicators
-Interact with local regulatory bodies during the development (e.g, pre-NDA meetings, formal and informal discussions, etc.), submission, review and post marketing phase

こんな方を求めています

経験・スキル

- Understanding Pharmaceutical Affairs Law and the relevant regulations in Japan
- Experiences/knowledge of the drug development in the CMC laboratories
- Knowledge/experiences of new drug applications in Japan for CMC part in accordance with Japanese drug regulations based upon scientific rationale
- Excellent oral and written communication skills in English

学歴

大学卒業以上

募集要項

職種

薬事、メディカルライティング

給与

年収 700 〜 1,400万円

賞与

-

雇用形態

正社員

雇用期間

期間の定めなし

就業時間

09:00～18:00

休日休暇

土曜日　日曜日　祝日

諸手当

-

保険

健康保険　厚生年金保険　雇用保険

受動喫煙防止措置

敷地内禁煙

特長

女性活躍中, 転勤なし, 外資系企業, フレックスタイム制, 年間休日120日以上, 完全週休2日制, 語学力を活かす

業種

医療機器・医療品関連

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