Preclinical Regulatory, Manager - Japan - Tokyo

BD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。 · ...

This role provides supervision, leadership, and line management of the Regulatory Start up team. This role will ensure that line reports are trained and managed to regulatory start-up process including regulatory authority (RA) and ethics committee (EC) submissions and approval. ...

We 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, ...

+We are now looking for in-country regulatory professionals to join our growing global regulatory team. · ...

This 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 . · ...

We're seeking a Manager of Regulatory Submission Project Management (RSPM) to lead the strategic planning and execution of regulatory milestones across our therapeutic areas. · Facilitate Global Regulatory Sub-team (GRST) meetings. · Create and manage submission timelines. · ...

Are you passionate about advancing health and wellness through innovative bioscience solutions?IFF is a global leader in flavors, fragrances, food ingredients and health & biosciences. · We deliver sustainable innovations that elevate everyday products. · Manage and develop produ ...

Are you passionate about advancing health and wellness through innovative bioscience solutions? IFF is a global leader in flavors, fragrances, food ingredients and health & biosciences. We deliver sustainable innovations that elevate everyday products. · ...

+Join a team where your expertise and ideas drive accuracy and innovation in regulatory reporting. · +Produce the Fund Holders Report (運用報告書), Fund Financial Report including Business/Profit & Loss reports, Financial Activity Report (事業報告書), and Bank for International Settlements ...

Join a team where your expertise and ideas drive accuracy and innovation in regulatory reporting. · ...

+Job summary · Create Japanese Package Inserts (JPIs) of new drugs and manage revisions of JPIs of post approval products to be in line with CCDS.ResponsibilitiesCreate Japanese Package Inserts (JPIs) of new drugs and manage revisions of JPIs of post approval products to be in li ...

The Regulatory Affairs Senior Manager focuses on regulatory activities from development to life cycle management with global and Japan stakeholders. · Lead RA-related Health Authority (HA) interactions. · Lead New Drug Application (NDA) · ...

We are seeking a full-time Regulatory Submissions Manager to join our Site Activation & Maintenance team in Tokyo, Japan. This position plays a key role in the clinical trial management process at Medpace. · Efficiently manage and successfully execute all aspects of global projec ...

This role provides supervision leadership and line management of the Regulatory team ensuring that line reports are trained and managed to regulatory process including RA approval according to ICH-GCP guidelines local regulatory requirements Novotech client standard operating pro ...

As a global leader in animal health Ceva Animal Health believes our success is linked to our passionate people researching developing producing and supplying innovative health solutions for all animals which contributes to the future of our diverse planet. · ...

Support Associate Director Regulatory Affairs EMEA/Japan to ensure compliance with regulations and statutes concerning development, manufacturing, distribution, marketing and sales of Hill's products in Japan. · ...

This role provides supervision leadership and line management of the Regulatory Start up team ensuring that line reports are trained managed to regulatory start-up process including regulatory authority RA ethics committee EC submissions approval site identification according to ...

We are now looking for in-country regulatory professionals to join our growing global regulatory team. · ...

We are now looking for in-country regulatory professionals to join our growing global regulatory team.This is an exciting opportunity to demonstrate your knowledge in leading regulatory processes for biological products and regenerative medicines in Japan. · ...

+Execute local preclinical documentation and manage outside service providers.+Bring local preclinical expertise to Japan Project Teams and Global Product Strategic Teams in Amgen+Ensure quality of contents and of Japanese translation of preclinical parts in CTD for J-NDA and IB ...