Compliance

• Participate in provision of regulatory expertise in strategic drug development across multiple areas.
• Take part in preparation of strategic development and submission plans.
• Be involved in the regulatory affairs activities across the ICON portfolio and be an expert and advisor to ICON clients (externally and internally).
• Be a trusted partner - represent the Regulatory Affairs Department in business development activities and generate new business opportunities.
• Contribute to at least two of the following areas: interactions with regulatory agencies, early phase consulting, development planning (PDP/RDP/CDP), scientific/agency advice, orphan drugs/pediatric development, medical devices, regulatory intelligence, due diligence, strategic CT support/GCP compliance, biological/biotech/biosimilars, small company support (incl. SOPs development etc.).
• PMDA 厚生労働省等の規制当局との面談・折衝
• 薬事分析(Regulatory Assessment)の実施
• Global PRA(欧州・アジア各国)およびクライアントとの協働
• Global PRAへの日本に於ける薬事要件のインプットと協議、協働
• 社内他部門との連携と薬事観点のアドバイス提供
• 薬事関連資料(各種面談資料、治験届等)の作成・作成リード
• 新薬申請から承認取得までの各種対応のリード
• 新規クライアントに対する、薬事戦略(Regulatory Strategy)の提案やプレゼンテーション
• チームメンバーのスキルアップへ向けたメンター業務

Senior Manager, Regulatory Affairs

Senior Regulatory Affairs Consultant – プロジェクトリーダー, プロジェクトマネジャー