薬事申請/特許技術関連 の 外資系・グローバル企業の転職・求人一覧

【業務概要】
数万点のヘルスケア商品を扱う日本向けECサイトの運営において、商品の新規開拓や薬学に関する専門的なアドバイスを行います。このほか、薬事コンテンツ作成など幅広い業務をお任せします。
当社にはWeb制作のプロが在籍していますが、案件を進行させるためには薬事・薬学に関する専門知識が不可欠です。
Webコンテンツや広告に関するアドバイスを通し、縁の下の力持ちとしてプロジェクト全 ...

将来を見据えて、更に充実が求められるJBP医療用医薬品の安全管理（ＧＶＰ）業務を担っていただきます。

【具体的な業務内容】
・医療用医薬品の信頼性保証に関わる業務（適切な運用及び管理、医薬品医療機器等法に関わる書類等の作成・申請・届出業務等）
・医療用医薬品の安全管理に関する事項
・ＧＶＰ省令遵守（安全性・有効性に関する情報収集、評価、対応）に関する事項
・医療用医薬品に関し ...

自社工場をもたないファブレスメーカーの品質保証業務をお願いします。

・海外・国内の製造工場において、製造管理基準（GMP）が守られているかチェックする

・製造管理基準を遵守し、ジャパンクオリティーを保つ仕組みづくり

・製品ラベルに必要事項が正しく記載されているかチェックする

・製品の品質保証をする為に製造工場から入手した情報を基に仕様書の作成を行う（英語・日本語）

・薬事 ...

Take lead in RA development strategy to obtain product approval. Work with the RA head to ensure PMDA submission of J-NDAs are aligned.


Description

* Take lead in RA development strategies/development
* Work with the RA head to ensure PMDA submission of J-NDAs are aligned
* As the RA lead work with other cross functioning departments to ensure company objectives are correct
* Develop key communication channels with the PMDA and other health authorities
* Be part of post-marketing RA responsibilities


Profile

* University degree ...

Be part of one of the top global regulatory consulting companies in the industry. Take lead in applications for compliance inspections to obtain licensing.


Description

* To process the application of the certificate of pharmaceutical product request to PMDA and the GMP compliance inspection application if necesary
* Coordination with assigned stakeholders and CMO sites to obtain GMP certificate
* To process the application of the GMP request to PMDA and the GMP compliance inspection application (if required)
* Coordination with assigned sta ...

Take lead in CMC RA activities for client needs on various projects. Lead the CMC RA Team.


Description

* Take lead in RA CMC strategy for company client's for various projects
* Lead the CMC RA department
* Develop CMC RA planning in terms of any change control activities, submissions, communication with the local health authorities (PMDA, MHLW) etc.
* Lead proper registration for client's facilties for FMA
* Execute regulatory strategies to align client's strategies
* Prepare in CTD documents to support in JNDA applications as well ...

Take lead in medical device RA activities for client needs on various projects. Act as a key consultant for class I-IV products for local regulations.


Description

* Support the planning and implementation for product registration in class I-IV products for the company's medical device clients
* Cover in various areas including in SaMD for end-to-end process of the product registration
* Be the SME for the business when it comes to RA area
* Ensure product registration translation work is correctly done
* Provide any local/regional reg ...

Be part of one of the top global rare disease company in the industry. Take lead in regulatory strategy/development to obtain product approval


Description

* Take lead in regulatory strategies/development to obtain product approval
* As a regulatory lead serve as a contact point for the business between local health authorities (PMDA)
* Communicate with global stakeholders to align company strategies from a regulatory point of view
* Prepare RA documents to develop product development plan
* Lead the submissions
* Liaison any local he ...