Job Description
The purpose of internship is to provide students who are interested in pharmaceutical industry with practical experience in regulatory affairs.
Through Hands-on Experience And Mentorship, Participants Will
- Gain insight and practical experience in the role of regulatory affairs in development of new generic drug submission and the preparation of packaging insert for generics that are parts of role of regulatory affairs in Sandoz K.K.
- Learn about the overview of development process of generics
- Optionally, experience collaboration with global team, depending on project availability and individual interest.
Key Competencies
- Teamwork and Collaboration: Willingness to work in cross-functional teams (e.g. R&D, Quality, Supply chain management)
- Learning Agility: Ability to quickly learn and adapt to new information. Demonstrate curiosity and initiative to explore industry-specific topics.
- Communication Skills: Active listening and appropriate response in team discussions.
- Scientific Literacy: Basic understanding of pharmaceutical or life sciences (e.g. chemistry, biology, analytical science)
Education
Science degree at University or College level. Master's degree or a degree in pharmacy is preferable.
Languages
Applicants should have proficiency in Japanese and be comfortable with reading and writing in English to support communication in a global work environment
Experience
Basic understanding of IT systems and tools, including proficiency in Microsoft Office.
-
Tokyo BD ￥9,000,000 - ￥12,000,000 per year+仅：department · ） +先 · ...
-
Minato-ku BD Full time￥6,000,000 - ￥12,000,000 per year호소는 정을 안세요 - · BD's Life Science Department (BioScience and Diagnostic Solutions Business) is integrating with Waters to become a leading company in the life science and diagnostic fields, specializing in high-volume testing in a highly regulated market. · ...
-
Tokyo BD ￥2,024,000 - ￥30,000,000 per year当社のライフサイエンス製品に関する薬事業務全般をご担当いただきます。具体的には以下の業務を担っていただきます。 · 製品登録プロジェクトのリード · (医薬品医療機器等法)に基づく登録申請書類の作成・提出 · 償還関連業務 · 区分の償還申請書類の作成・提出、E2・E3区分の償還取得サポート · 製品ラベリングのレビュー・承認 · 登録書類と整合性を保つためのラベルや関連資料の確認 · 広告・販促資材(AdProm) のレビュー・承認 · 事業部門:ビジネス戦略を理解し、薬事戦略や進捗を共有 · Regulatory(海外):製品登録に必要な情報のはて ...
-
Minato BD Nogales Norte当社のライフサイエンス※製品に関する薬事業務全般をご担当いただきます。具体的には以下の業務を担っていただきます。 · ...
-
Tokyo BD ￥100,000 - ￥200,000 per year+ · + · +h2+bJob summary/b/h2+pThe Senior Manager responsible for all aspects of regulatory affairs for BDB and DS./ppressible for all aspects of regulatory affairs for BDB and DS.+h2+bJob Description Summary/b/h2+pResponsible for all aspects of regulatory affairs +/pposition ove ...
-
Tokyo Sandoz ￥80,000 - ￥120,000 per yearThe purpose of internship is to provide students who are interested in pharmaceutical industry with practical experience in regulatory affairs. · Through Hands-on Experience And Mentorship, Participants Will Gain insight and practical experience in the role of regulatory affairs ...
-
Tokyo BD ￥25,000,000 - ￥35,000,000 per year· BD 안세요 전속,Waters Corp.첟BD안세요 전속,Waters Corp. ...
-
Minato-ku BD Full time￥1,584,000 - ￥2,442,000 per year薬事担当シニアマネージャーは、ライフサイエンス部門の薬事機能を統括し、バイオサイエンス事業部と診断ソリューション事業部の両方を統括します。体外診断用医薬品(IVD)関連規制を含む国内外の規制へのコンプライアンスを確保するための薬事戦略の策定と実行을担当します。 · ...
-
Minato BD Nogales NorteBDは、ヘルスケア分野における多様なニーズに応える医療技術、デバイス、実験機器を開発する世界をリードする医療技術企業です。感染症の撲滅と治癒を目指す戦いにおいて最先端の研究を提供し国内外の人々に画期的な医療・バイオテクノロジーサービスへのアクセスを向上させるという私たちの使命で、私たちが求めています。 · ...
-
Tokyo The businesses of Merck KGaA, Darmstadt, Germany Full timeLife Science Regulatory Management、レギュラリースペシャリストとして業務を行う。東京勤務、週2日在宅ワーク可。 · ...
-
Tokyo ZOLL Medical CorporationThe Regulatory Affairs Manager is responsible for overseeing the preparation of regulatory submissions required to market new or modified devices in both domestic and international markets including all relevant maintenance activities. This position will also oversee the preparat ...
-
Greater Tokyo Area IntelliProLead regulatory affairs in Japan for pharmaceutical products. · ...
-
Tokyo, Tokyo iNova Pharmaceuticals ￥4,500,000 - ￥8,000,000 per yearThe Company is seeking a Regulatory Affairs Manager to join its team on a full-time basis. The position is responsible for setting & executing the Japan regulatory strategy, managing product registration and maintenance, local regulatory support for the new product launch and loc ...
-
Tokyo, Tokyo GE HealthCare ￥6,000,000 - ￥12,000,000 per yearWe are seeking a highly motivated Regulatory Affairs Manager to lead regulatory strategies and ensure compliance for pharmaceutical and medical device products. This role plays a critical part in supporting product launches, ...
-
Tokyo, Tokyo Merck Life ScienceWe are seeking a Regulatory Affairs Expert to join our team at Merck. · Maintain regulatory approvals for In Vitro Diagnostics (IVD) and Medical Devices, · Acting as an agent for Foreign Manufacturer Accreditation, · Preparation of DMF for APIs and excipients, · API Import licens ...
-
Greater Tokyo Area Kingfisher HR Solutions GroupThis position offers a unique opportunity for growth with an international cosmetics manufacturer expanding into Japan. · The role involves managing compliance systems for pharmaceuticals , quasi-drugs ,and cosmetics . · ...
-
Regulatory Affairs
2ヶ月前
Tokyo ZOLL Medical Corporation ￥6,000,000 - ￥9,000,000 per yearThe Regulatory Affairs Manager is responsible for overseeing the preparation of regulatory submissions required to market new or modified devices in both domestic and international markets including all relevant maintenance activities.This position will also oversee the preparati ...
-
Tokyo Digisailor Full timeWe are supporting a global life sciences organization in identifying an experienced Japan Regulatory Affairs Lead (CMC-focused). · ...
-
Tokyo DigisailorWe are supporting a global life sciences organization in identifying an experienced Japan Regulatory Affairs Lead (CMC-focused) to define and execute Japan-specific CMC regulatory strategies. · 10–15+ years of experience in Japan Regulatory Affairs (Pharmaceuticals). · ...
-
Tokyo, Tokyo AbbottThis role involves working as a specialist in regulatory affairs. · ...
-
Tokyo, Tokyo Leica Biosystems ￥1,500,000 - ￥2,000,000 per yearAs a Principal Specialist in Regulatory Affairs at Leica Biosystems, you will be responsible for ensuring new or sustaining products receive regulatory approvals within a timely manner. You will collaborate with stakeholders to manage quality issues and maintain GVP documents. · ...
