新規ビジネスに関連する薬事承認を速やかに取得するための情報の入手及び早期の申請及び適切なタイミングで届出を行う。薬事規制を遵守するため、チームで合意された内容に則り、適切な対応を行う。申請以外の担当業務について、プロジェクトリーダーとして中心的な役割を果たす。 · ...

The Regulatory Affairs Specialist plays a crucial role in ensuring that medical devices and equipment comply with regulatory requirements. They are responsible for preparing and submitting product applications with the Japanese Ministry of Health, Labour and Welfare (MHLW) to obt ...

This position involves handling regulatory affairs for medical devices in Japan, ensuring compliance with regulations and obtaining necessary approvals. · Create and submit regulatory documents, respond to inquiries, and obtain approvals from the PMDA and other authorities. · ...

Regulatory Affairs Specialist will be responsible for developing product characteristics-based regulatory strategy · ...

senior regulatory affairs specialist · 製造販売承認取得及び既存製品の維持管理業務 · 製品の特性やニーズに沿った承認申請戦略の立案 · ...

· メディカルエデュケーション&コミュニケーション部スタッフ · FAQの作成 · ローカルレスポンスドキュメント(LRD)の作成 · コールセンターの運営 · 2次エスカレーション対応 · グローバル質問対応管理サイト(One GMIの管理) · . FAQシステムの構築(外部サイト、社内Webページなど). 外部ベンダー管理 Li. ...

国内のマルチチャネルマーケティングチームの一員として、医療従事者とのエンゲージメントを高め、革新的な製品・サービスの価値を最大限に伝えるためのデジタルおよびソーシャルメディア施策の実行 · また、日本国内に加え、グローバルチームのマーケティング活動もサポートします。 · ソーシャルメディア、ウェブサイト開発、Eメールマーケティング、アナリティクスなどの知見を活かし · , · , · ...

The Medical Science Liaison (MSL) role involves exhibiting scientific and clinical knowledge to facilitate timely and appropriate exchanges with influential external experts. · Exhibits strong knowledge of relevant diseases, healthcare environment, competitors; can articulate med ...

The job involves technical leading regulatory compliance management for Beauty products in Japan. The responsibilities include conducting concept/category reviews, label and claims development, international claims support and investigation of products. · ...

The Deputy Country Quality Head will lead the implementation and maintenance of GxP quality systems in Japan. The role requires strong leadership skills and experience in quality system management, with a focus on compliance with health-regulated regulations. Key responsibilities ...

The GCDSE provides clinical and R&D expertise in their region/country. · Accountable for global protocol development · Ensures consistency across trials in terms of site selection approval process · Responsible for country/regional interactions with regulatory authorities · ...

Provides Japanese Labelling & Artwork Regulatory expertise across a Therapeutic business unit. Delivers strategic and operational regulatory input and guidance to the cross functional teams. · Creation, update and maintenance of the Japanese package inserts in line with the CCDS, ...

Roles providing expertise on scientific topics regarding relevant disease areas and Company assets to ensure their safe and appropriate use by patients. · Acts as a field-based expert, building relationships with External Experts as trusted scientific partners. Exchanges credible ...

Clinical Science Lead also known as Sr Clinical Scientist responsible for leading regional country level Development Team in matrix setting ensure alignment across key stakeholders promote team work drive development Clinical Development Plan CDP relevant study designs team effor ...

Clinical trial experience is required of MDs with over 3-5 years of corporate experience and development experience who hold Japanese medical licenses. · ...

Leads the development team to ensure alignment across key stakeholders and promote teamwork. Drives the development of Clinical Development Plans (CDPs) and relevant study designs through team effort. · ...

The primary purpose of a Project Manager (PM) is to ensure and elevate the level of country operations to realize patient value by transforming company's strategy into project delivery in Japan. · ...

The Pricing Strategist will be responsible to achieve UCB's Pricing & Access objectives for the pipeline portfolio (with focus on BKZ, rare diseases, Briviact and Staccato in mid-term). · Central to the role will be maintaining a clear view on priority opportunities to focus on, ...

The Safety Specialist collaborates with teams to ensure safety communication and product stewardship. · ...

The Medical Science Liaison (MSL) is field-facing role whose main objectives are to be the trusted scientific partner to key external experts and execute on stakeholder engagement plans to gather data and develop medical insights that contribute to enhancement of key medical mess ...

The Medical Science Liaison (MSL) is field-facing role whose main objectives are to: Be the trusted scientific partner to key external experts by conducting timely, appropriate and frequent scientific exchanges to enhance the understanding of the scientific and medical value of o ...