ライフサイエンス分野薬事・学術のLife Sciencesの求人

開発計画の支援や薬事戦略の提案、承認申請の実施・管理を担当します。国内外の薬事関連業務を通じて、医薬品の研究開発に貢献します。

• 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

• 希少疾患の新薬の承認申請業務（薬事戦略の立案、書類の作成、PMDA対応等）

• 提出戦略の策定およびプロジェクト計画文書のレビュー
• 日本国内の臨床試験の申請書類作成と提出

• 規制および倫理委員会への提出書類（輸入・輸出ライセンス申請を含む）の準備
• 規制プロジェクト文書のフロー管理と進捗報告

• 規制当局および倫理委員会への提出書類（輸入・輸出ライセンス申請を含む）の準備
• 規制プロジェクト文書のフロー管理と進捗報告

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.

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.

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

• 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

Take lead in CMC RA submissions and development strategy to obtain product approval. Prepare CMC documentations and management of post-approval CMC.

• 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

As part of the global RA team, support in RA activities to obtain regulatory approval for companies products and post approval maintenance. Align company strategies to align with local regulations.