外資大手製薬 開発薬事

求人会社名 : 会社名非公開

  • エージェント取り扱い求人

募集要項

仕事内容 1. Assist developing innovative and high quality regulatory strategies to facilitate regulatory processes in development and ensure registration with optimized labels that contribute to health and welfare of the Japanese nation.

2. Contribute to the regulatory activities in day-to-day operations for assigned TA area.

3. Lead cross functional communication for preparing and finalizing Japanese labeling for new drugs.

4. Take regulatory related actions to maintain post marketing products in Japan.

5. Establish goodrelationship with the Japanese HA in responsible projects

6. Contribute to the adherence to regulations, guidelines and global/internal procedures.

7. Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures

8. 100% timely delivery of all training requirements including compliance
応募資格 Education:
Degree in pharmacy, medicines, science, agriculture and/or pharmaceutical engineering discipline required and advanced degree preferable. Pharmacist license preferred.

Experience/Professional requirement:
1. Demonstrate good presentation skills in delivering clear messages to audience and modifying language and style to meet the needs from audience.
2. Understand the drug development/maintenance processes, milestones in the assigned disease area and the company procedures for decision board review and approval.
3. Understand basic knowledge of Japan regulation
4. Possess basic knowledge of global regulatory environment, and contribute to elaborating the project specific development/regulatory strategy and plan.
5. Report and summarize discussions in which RA plays an important role.
6. Good in writing and reading English (e.g. exchange of scientific and technical information by e-mail and generation of scientific and technical documentation).
7. Proactively communicate issues and potential solutions.
8. Provide updates on current situation, and ensure that the same information is disseminated throughout the organization as needed.
9. Network with others and share information.
10. Demonstrate cultural awareness and work in cross cultural environment.

English Skill:
Fluent English as business language.
年齢 25歳~42歳まで
【年齢制限理由】
技能等の継承の観点から特定の職種において労働者数が相当少ない特定の年齢層に限定するため
勤務地 東京都
勤務時間 9:00-17:45 (フレックスタイム)
年収・給与 想定年収:500-1000万位(経験、前職での報酬を考慮)

求人会社概要

求人会社名 会社名非公開
概要 幅広い領域の医薬品の開発、輸入、製造、販売を行うヘルスケアにおける世界的リーディングカンパニー。
業種 食品・医薬品・化粧品

この求人の取扱い紹介会社

株式会社ドルチェインターナショナル (Dolce International Inc.)

株式会社ドルチェインターナショナル(Dolce International Inc.)

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