We are seeking a full-time, office-based Regulatory Submissions Coordinator to join our Clinical Operations team. · ...

We are seeking a Regulatory Submissions Coordinator to join our Clinical Operations team in Japan. This position plays a key role in the clinical trial management process at Medpace. · Quality check on submission documents and site essential documents; · Interaction with US Centr ...

The Manager, Regulatory Submissions manages high impact, complex submission projects involving multiple cross-functional regulatory submission teams. · Independently manages high impact (with respect to internal visibility, risk, complexity and criticality) submission projects to ...

Senior Regulatory Legal Services Coordinator will provide professional company secretarial services to clients in Japan region with core areas of responsibility. The role will report to the Corporate Secretarial Manager. · Provide service to clients on company secretarial matters ...

The opportunity to develop regulatory strategy, prepare and execute regulatory submissions for innovative products in Japan, with a strong understanding of local regulatory requirements and experience leading regulatory activities. · Create proactive and robust regulatory strateg ...

The Pharmacovigilance (PV) Associate is responsible for supporting the pharmacovigilance system to ensure compliance with both local and global regulatory requirements. · Adverse Event (AE) Case Management · Receive, review, and process adverse event reports from various sources ...

The CMC Regulatory Strategy Manager will coordinate the CMC regulatory strategy activities for assigned projects, manage the CMC Regulatory relationship with Global CMC, and execute CMC Module finalization of J-NDA. The role will also lead the development of CMC regulatory strate ...

The Senior Regulatory Affairs – CMC Specialist will be responsible for leading and supporting Chemistry, Manufacturing, and Controls (CMC) regulatory activities related to product development, registration, and lifecycle management for the Japanese market. · Author, review, and m ...

The 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 ...

The 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 ...

Supports the Global Regulatory Lead in the development and execution of the regulatory strategy. Responsible for operational and tactical project management to ensure satisfactory completion of regulatory milestones. · Bachelor degree; preferably in a pharmacy, scientific or tech ...

Alber Blanc is an international prop high frequency trading company with more than 13 years of experience. We are seeking an experienced professional based in Japan to oversee local operations of a company focused on trading financial instruments on a part-time basis or full-time ...

Develops and implements processes involved with maintaining annual licenses, registrations, and listings, reviews and approves advertising and promotion to ensure regulatory compliance, assures post-market regulatory requirements are met, submits notifiable changes and supplement ...

We are currently seeking a Study Start Up Associate II to join our diverse and dynamic team. · ...

We are currently seeking a Study Start Up Associate II to join our diverse and dynamic team. · Leading the preparation and submission of regulatory documents, · including clinical trial applications, ethics committee submissions, · and regulatory agency communications. · ...

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the glob ...

This position will be responsible for leading all medical device Regulatory Affairs activities which include product submissions, develop regulatory strategies, change assessments, commercial supports, compliance related activities, systems/process improvements and other responsi ...

We are looking for a passionate and detail-oriented Medical Writer to join our client in Japan. In this role, you will create high-quality scientific and regulatory documents that support drug development, clinical research, and medical communications. · Write, edit, and review c ...

The Operations Regulatory Reporting team is responsible for ensuring Société Générale meets its regulatory obligation for key non-financial regulatory reports. · Post Trade Transaction and Position report production and submission, Monitoring of Report submission schedule and st ...

Seeking a Legal Counsel based in Japan to provide strategic legal support for some huge project. · Provide practical and timely legal advice on development, regulatory, and corporate matters. · Draft, review, and negotiate complex commercial and project agreements. · Partner with ...

As a Regulatory Officer, you will work closely with our global team of experts to prepare clinical trial dossiers for regulatory and authorities, deliver regulatory training to project teams, and communicate with stakeholders on regulatory-related matters. · Prepare clinical tria ...