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  3. PSI CRO Japan株式会社:薬事・規制関連業務担当者(Regulatory Officer)の求人情報詳細

薬事・規制関連業務担当者(Regulatory Officer)

PSI CRO Japan株式会社

想定年収

600万円 ~ 1,000万円

勤務地

大阪府 東京都

従業員数

30名(2026年2月)

仕事内容

As a Regulatory Officer, will work closely with our global team of experts to prepare clinical trial dossiers for regulatory and authorities, deliver regulatory training to project teams, and communicate with stakeholders on regulatory-related matters.
Join PSI and help drive innovation and excellence in advancing healthcare solutions.


Prepare clinical trial regulatory submission dossiers, including applications for import and export licenses
Track regulatory project documentation flow and progress reporting
Review translations of essential documents subject to clinical trial submission
Liaise with project teams to procure documents necessary for regulatory submissions
Communicate with regulatory authorities, sponsors, and vendors on all regulatory-related matters
Track changes/amendments to legislative acts pertaining to clinical trials in Japan
Review documents to greenlight IP release to sites
Manage safety reporting to authorities
Deliver training on regulatory environment in Japan
Participate in the regulatory aspects of feasibility research

仕事内容変更範囲

会社の指示する業務

職位

募集背景

日本法人立ち上げに伴う増員での募集

募集人数

1人

応募条件

技能/経験

・University degree in Life Sciences, Medicine or Pharmacy or an equivalent combination of education, training, and experience
・Experience with clinical trial submissions to PMDA
・Knowledge of the regulatory environment for clinical research
・Full working proficiency in English and Japanese
・Detail-oriented
・Communication, collaboration, and problem-solving skills

学歴

大学

職務経験

業界経験

年齢

年齢制限不問  

英語力

中級以上

その他語学力

語学力詳細

勤務条件

雇用形態

無期雇用

試用期間

有り(6か月)

給与

年俸制

年収:600万円 ~ 1,000万円

月収:50万円~83万円

月額基本給:50万円~83万円

ご経験次第でオファー金額は要相談

賞与・インセンティブ

年1回  

昇給

有り 年1回

勤務地

大阪府 東京都

東京:千代田区丸の内二丁目6 番1 号丸の内パークビルディング8 階xLINK 丸の内(区画No. 15 )
大阪:大阪市北区梅田2-2-2 ヒルトンプラザウエストオフィスタワー18階

交通手段1 沿線名:各線 駅名:東京 最寄駅から:徒歩1分

交通手段2 沿線名:各線 駅名:大阪 最寄駅から:徒歩3分

勤務地変更範囲

会社の定める事業所

出向

就業時間

09:00~18:00

休憩時間:60分

残業:月5時間~20時間程度

フレックスタイム制
コアタイム 11:00 ~ 14:00

残業手当

通常の残業代

通勤手当

交通費:全額支給

その他手当

休日・休暇

完全週休二日制, 土, 日, 祝日, 年末年始

年間休日:125

年間有給休暇:初年度 最大10日(入社月によって異なる)

社会保険

雇用保険, 健康保険, 労災保険, 厚生年金

福利厚生

各種社会保険完備

受動喫煙対策

就業場所 全面禁煙

備考

選考内容

選考プロセス

適性試験:無し 面接回数:2回

求人No.:NJB2327428

最終更新日:2026/1/23

企業情報

企業名

PSI CRO Japan株式会社

代表者名

代表取締役 Nick Sinackevich (シナケヴィッチ・ニック) PSI Japan Country Manager: Sayaka Kaji (梶さやか)

設立

2024年9月

従業員数

30名(2026年2月)

資本金

10,000,000円

本社所在地

〒103-0025 東京都千代田区丸の内二丁目6番1号 丸の内パークビルディング8階xLINK丸の内(区画No.15)

株式公開

日系・外資

外資

事業内容

PSI is a leading Contract Research Organization (CRO) with over 25 years of experience in the pharmaceutical industry. Originating from Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we undertake highlights our commitment to delivering high-quality, timely services across a broad spectrum of therapeutic indications.

In an industry where cost-cutting and layoffs are common, PSI stands out as a stable and secure workplace. Our dedication to stability is evident in our exceptionally high repeat and referral business rate and minimal staff turnover. Many of our colleagues have been with us for over 15 years, contributing to our long-standing traditions and history. Our expansion into Japan continues this legacy, and we seek team members who will grow with us for the long term.
At PSI, we foster an environment where a diverse range of colleagues feel welcomed and valued. Our inclusive culture is a cornerstone of our success, enabling us to attract and retain top talent globally.

We are not just about conducting clinical trials; we are about building a community where every team member has the opportunity to thrive and contribute to groundbreaking advancements in the pharmaceutical industry.

事業に関する特色

■Mission
Our mission is to be the best CRO in the world as measured by our employees, clients, sites, and vendors.

Employees come first because being in the people business, we know only happy employees can make happy clients, sites, and vendors. In fact, we do not like the word “employees” and hardly ever use it. We prefer to say “teammates”.

We work in teams, and that shapes our collective mindset. Connection and interdependence are important to us and we devote time, attention, and funds to bring teams together. Many newcomers quickly comment on the uncommon team atmosphere they perceive here from day one.

■Management
PSI is privately owned by a group of managers who set it up a quarter of a century ago and still come to work every day.

These folks succeeded in keeping the company fully independent. In our industry, this is unique and gives us great advantage and freedom.

The power distance within PSI is very short. It is routine for our upper level officers to be involved in all sorts of dialogue with teammates of all levels. We make a point to be approachable, receptive to new ideas, and open to feedback. After all, we want to identify our weaknesses before the market does.

Both our country and functional management have a fair degree of autonomy in making decisions and creating an engaging working environment. They have operational freedom to make nuanced country-and department-specific adjustments while nurturing the global PSI culture that unites us across six continents.


■The PSI Advantage
PSI CRO has received 2024 CRO Leadership Awards in the categories of Expertise, Quality, Compatibility, and Reliability in the Overall (combined Big and Small Pharma) respondent group. This is the seventh consecutive year that PSI has received leadership awards presented by Clinical Leader and Life Science Connect based on research conducted by ISR. The awards recognize CROs that are voted by sponsors to meet or exceed expectations.

会社の特色

その他の特色

売上実績

求人No.:NJB2327428

最終更新日:2026/1/23

  1. ハイクラス転職TOP
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  3. PSI CRO Japan株式会社:薬事・規制関連業務担当者(Regulatory Officer)の求人情報詳細