·  · DMF new,（original drug and additives etc.）and manufacturing to contact the DMF · foreign manufacturer certification agent business · ...

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 · 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。 · ...

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

Contributes significantly to ensuring products are available on a timely and continuing basis in Japan by performing regulatory affairs tasks related to new product applications, existing product change management and approval maintenance. · ...

manufacturing approval acquisition and maintenance management business product characteristics and needs based approval strategy formulation application strategy and manufacturing original documents based approval application creation administrative authorities inquiries response ...

The GCDSE provides clinical and R&D expertise in regional/country context. They lead global project teams, provide medical guidance on safety protocols, interact with regulatory authorities, · and contribute to scientific publications. · Physician training in Pediatrics or Intern ...

The Medical Science Liaison (MSL) is a field-facing role whose main objectives are to exhibit scientific and clinical knowledge of diseases and vaccine development. The MSL is expected to build strong internal relationships with colleagues while maintaining full compliance with a ...

The Lead Program Manager will develop and implement strategic plans to foster positive awareness of the company with outside audiences. · - Implement strategic plans to foster positive awareness · - Manage downline staff and delegate responsibility · - Collaborate across function ...

Technical leading regulatory compliance management for Beauty products in Japan: · - Engaging in global projects for regulatory affairs digital transformation and support Japan I&S to develop regulatory compliance guideline in line with global digital transformation · Evaluati ...

Provides Japanese Labelling & Artwork Regulatory expertise across a Therapeutic business unit. Delivers strategic and operational regulatory input and guidance to the cross functional teams. · ...

Clinical Science Lead: Responsible for overall implementation of the Clinical Development Plan to ensure timelines and deliverables are within expectation. · ...

Clinical trials experience is mandatory for this role. Applicants should have at least 3-5 years of corporate experience and hold a Japanese medical license as an MD. · Assume overall responsibilities as a regional/country level Development Team leader in the matrix setting to en ...

This MSL Oncology role will provide expertise on scientific topics regarding relevant disease areas and Company assets to ensure their safe and appropriate use by patients. · ...

The Safety Associate will implement and maintain a pharmacovigilance system for UCB products authorized in the territory ensuring compliance with applicable regulatory requirements. · ...

Lead the Development Team to ensure alignment across key stakeholders and promote teamwork. Drive development of Clinical Development Plan (CDP) and relevant study designs. · ...

The Deputy Country Quality Head will lead the implementation and maintenance of GxP quality system with respective operation units. · ...

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.PMs will support the project sponsor, who has overall accountability and team leadersh ...

The Safety Specialist will collaborate with the Process Management Team members and the Product Management Team members to ensure Safety communication and product stewardship. They will ensure that Pharmacovigilance systems, operations and procedures are in place within the local ...

We are seeking an experienced, highly motivated and talented individual to play a Technical application Expert role in a dynamic team. · ...

Serve as a clinical and post-marketing medical safety expert in the country Accountable for all signal management activities in the country & ensures that the local product labels and risk management plans are properly aligned with the benefit risk of the products. · ...

This role provides expertise on scientific topics regarding relevant disease areas and Company assets to ensure their safe and appropriate use by patients. The Medical Science Liaison collaborates with internal and external stakeholders to translate scientific data and medical in ...