ライフサイエンス分野薬事・学術のライフサイエンスの求人

Be part of one of the top leading global life science companies in the industry. Take lead in RAQA activities for the business as the "Sokatsu".

• 新製品の承認戦略とスケジュール策定、既存登録の維持、デザイン・製造プロセス変更の影響評価
• ステークホルダーとの協力による新製品の円滑な導入

• 日本及び国外の薬事法則に関する情報収集、またclientとの情報共有
• 薬事戦略の立ち上げ、CTDを含める申請書類の作成、当局対応の助言

• 国外・国内のクライエント及び自社製品の開発薬事戦略の立案、承認申請のproject management
• ICCC、CTD等の申請資料の作成・提出、申請後の照会事項対応、PMDA対面助言等

• 新薬の開発において、プロジェクトに早期から取り組み、製品の特徴を評価し、関連法規やガイドラインに基づいて開発薬事戦略を立案する
• 薬事戦略に基づいて臨床試験計画を策定し、規制当局と協議し合意を取得する

• 薬事戦略を立案・実行し、当局対応をリードします。
• 開発計画の支援と承認申請プロセスを管理します。

Be part of one of the top largest global diagnostics companies in the industry. Lead in RA activities for the business to obtain product approval/maintenance.

Be part of one of the top global healthcare consumer companies in the industry. Take lead in RA labeling activities to ensure product approval/maintenance.

Be part of one of the top global pharmaceutical company in the industry. Lead in RA development activities to obtain/maintain regulatory approval

Take lead in CMC RA activities to obtain product approval. Collaborate with local/global CMC RA teams to align overall business strategies

Lead in RA strategies and submissions to obtain product approval. Lead the RA team.

Take lead in RA development activities for the business to obtain regulatory approval for new products. Lead the RA department.

Take lead in RA activities to obtain approval for new/existing products. Provide key guidance in regulatory strategy/development.

Take lead in RA development/strategies to obtain product approval. Communicate with global stakeholders to align successful product registrations.

Take lead in RA activities for the business to obtain approval for company's products. Partner with global stakeholders and regulatory authorities.

Be part of a top 10 Global CRO that's entering the Japan market as a first member. Lead in RA activities to submit clinical trial documents to obtain approval.

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

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

• サンプルテストやJPラベルの作成
• サンプル倉庫の管理とサービスプロバイダ監査

• 新製品の承認戦略とスケジュールの策定
• 既存登録の維持とデザイン・製造プロセス変更の影響評価

Take lead in CMC RA activities to obtain/maintain regulatory approval. Be in charge of hands-on management of new products, line extension, and maintenance from a technical as well as operational point of view.

• Responsible for the submission of global regulatory documents
• Manage the compilation and archiving of regulatory submissions

Be part of a leading global medical device company specialising in digestive and pain management products. Lead in RAQA activities as well as the department.

薬事業務