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現在の検索条件

求人掲載言語 :日本語での求人登録

4件中14件を表示

人材紹介 社名非公開
  • ハイクラス
  • ★ ★ ★ ★ マネージャーレベル
仕事内容

Lead in RA activities to obtain regulatory approval for company products. Expand the business into the Japanese market.


Description

* Lead in regulatory submissions for company products to obtain product approval
* Develop effective regulatory strategies and collaborate global stakeholders to align business growth
* Communicate, negotiate, develop key relationships with health authorities (PMDA, MHLW, etc.)
* Be the key person to share necessary regulations/compliance requirements in Japan
* Manage any regulatory changes, procedures, ...

人材紹介 社名非公開
  • ハイクラス
  • ★ ★ ★ ★ マネージャーレベル
仕事内容

Lead in RA activities to obtain regulatory approval for company products. Expand the business into the Japanese market.


Description

* Lead in regulatory submissions for company products to obtain product approval
* Develop effective regulatory strategies and collaborate global stakeholders to align business growth
* Communicate, negotiate, develop key relationships with health authorities (PMDA, MHLW, etc.)
* Be the key person to share necessary regulations/compliance requirements in Japan
* Manage any regulatory changes, procedures, ...

人材紹介 社名非公開
  • ★ ★ ★ シニアレベル
仕事内容

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 ...

人材紹介 社名非公開
  • ハイクラス
  • ★ ★ ★ ★ マネージャーレベル
仕事内容

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 ...