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

セルロースなどの天然由来の繊維の販売を行うレッテンマイヤージャパンでは、ファーマ部門でのテクニカルアシスタントを募集します。

【ファーマ部門について】
JRS Pharmaはセルロースを原料とする医薬添加剤の世界のマーケットリーダーの1つとして、錠剤、カプセル、その他剤系の医薬品および健康食品の製造に使用されています。

大手製薬メーカーや特殊製品の製造メーカーの皆様に、当社製品の信頼 ...

Take lead in diverse range of RA projects to support clients in obtaining regulatory approval. Provide expertise in RA strategy/development.


Description

* Lead in multiple RA projects to support clients in obtaining regulatory approval
* Provide expertise in RA development/strategy
* Create appropriate materials and provide consultancy advice to implement best practice
* Lead in business development to partner with new clients to increase business
* Share strategic advice for regulatory applications and communications with health auth ...

Be part of a global renown biopharma with rich development pipeline. Take lead in CMC RA activities to obtain regulatory approval.


Description

* Take lead in CMC RA activities for the business to obtain regulatory approval of new/existing products
* Prepare CTD documents (such as module 3) and other application form for submission
* Communicate with health authorities such as the PMDA for consultations and inquiries
* Collaborate with global stakeholders to align company strategies
* Ensure effective regulatory compliance requirements ...

Be part of the RA department in leading regulatory submissions and approval for company's products in the Japan market. Lead in regulatory affairs strategies to align with global objectives.


Description

* Take lead in regulatory development/strategy for new drug applications to obtain approval
* Communicate with regulatory bodies and other local health authorities
* Ensure compliance with Japan standards to align company strategies
* Manage in project submissions in an appropriate manner
* Work with cross-functional departments to alig ...

Lead in new product launch submissions to obtain regulatory approval for Japan. Align company strategies to align with local regulations.


Description

* Take lead in RA activities for the business to obtain and maintain regulatory approval for company's products as a member of the global RA organization
* Work with cross functioning departments to align company strategy for the Japan market
* Prepare document submissions with company's time line
* Communicate with regulatory bodies and local health authorities
* Be part of the RA devel ...

Take lead in regulatory submission activities for the business to get product approval. Be involved in publishing and archiving activities to ensure best practices.


Description

* Lead in regulatory operations in submissions and being informed of up to date regulatory information to manage tracking systems
* Be the main point of contact in electronic submissions, including new data requirements tracking regulatory data for RIM system
* Create eCTD documents and electronic JNDA Data to the PMDA and other health authorities
* Manage any reg ...