Lead Japan CMC strategy for innovative global pharma projects, gain full product lifecycle experience from R&D to post-market. · Develop and implement innovative Japan regulatory CMC strategies for development and marketed products · Lead regulatory interactions with PMDA/MHLW, i ...

The Associate Principal Scientist, Regulatory CMC Japan will be accountable for assessment of changes for regulatory impact, development of Japan CMC strategy, preparation of CMC documentation and execution of post-approval CMC supplements and new product registrations for the en ...

The CMC RA Manager will lead and manage CMC regulatory activities, develop and implement CMC registration strategies, and support the development of the CMCRA team. The ideal candidate will have +10 years of practical experience with CMC-related roles, experience drafting and com ...

Genmab is a global biotechnology company that aims to improve patients' lives through innovative antibody medicines. We are a passionate and innovative team that has developed a next-generation antibody technology platform over 25 years, using translational science, quantitative ...

DM · リアルワールドDMでは、PMS案件に加え、Global Pharmaの臨床研究やアカデミア主導の医師主導治験等も担当しています。 · ...

Lead and manage CMC regulatory activities including relevant cross-functional communication, providing guidance across the product lifecycle, and ensuring timely regulatory compliance with official guidelines. Develop and implement CMC registration strategies related to CTNs, NDA ...

To conduct change control of approved products appropriately as CMC-regulatory affairs (CMC-RA). To prepare application dossiers for CMC part and to communicate with HA appropriately to contribute in obtaining regulatory approval. · ...

To conduct change control of approved products appropriately as CMC-regulatory affairs (CMC-RA). To prepare application dossiers for CMC part and to communicate with HA appropriately to contribute in obtaining regulatory approval. · ...

BeOne is seeking an experienced regulatory professional to manage and evaluate regulatory projects. · ...

This is a key middle management role with both local and global impact at Ferring Pharmaceuticals, offering a unique opportunity to contribute to both local GQP/QA operations and global Quality Management System (QMS) initiatives and the operations. · Influence both local and glo ...

Join our dynamic team as a CMC (chemistry, manufacturing, and controls) Expert, where you will play a pivotal role in shaping regulatory strategies and ensuring high-quality submissions to authorities like PMDA/MHLW. Leverage your expertise to collaborate with global teams, shari ...

Responsible for submission document preparation concerning CMC parts of NDA, PCA (Partial Change Application) and NMC (Notification of Minor Change) according to the agreed timelines to get the approval in Japan. With regard to Marketed Products, responsible for regulatory evalua ...

The ideal candidate will direct the business development activities of the organization and drive the sales business. · Lead key BD processes such as new business demand generation including NDA/ MSA processing, RFP generation, coordination of technical discussions, pricing final ...

Join our dynamic team as a CMC Expert, where you will play a pivotal role in shaping regulatory strategies and ensuring high-quality submissions to authorities like PMDA/MHLW. · Prepare high-quality J-QOS documents, application sheets, and responses to inquiries from PMDA/MHLW in ...

We are seeking a strategic business leader to drive growth for a leading healthcare solutions provider in Japan. This role offers the opportunity to shape the business unit strategy, lead cross-functional teams, and build strong partnerships with pharmaceutical clients and key st ...

Our client, a leading European CDMO and top player in the global pharmaceutical industry, is currently looking for a Business Development Manager - Japan. · Develop and execute tailored sales strategies in collaboration with the Head of Sales, Regional Manager, Commercial Excelle ...

Trojan Technologies provides innovative water treatment solutions. The Key Account Manager is responsible for strategically driving growth and expansion of direct/indirect sales and profit margins for TT with the Commercial teams, Subsidiaries and Channel Partners (CP). · Develop ...

As a passionate Technical Consultant, you will be responsible for consulting, solution/problem-solving, and empowering our clients' data journey using Data Virtualization. · Be part of an elite team in a rapidly growing international software product company. · Conduct on-site an ...

We are a fast-growing, international organization with teams across four continents and we work with a cutting-edge technology, but that's not all we have to offer. At Denodo, we are like a family and it is of the utmost importance to us that we help support your professional gro ...

We are seeking a Senior Manager/Manager RA CMC to join our team at Genmab. · We are committed to improving patients' lives through innovative antibody-based medicines. · Make a strategic J-NDA plan for RA CMC · & execute; · Draft J-CTD (m3) · & realize high-quality J-CTD; · ...

The Account Development Representative drives pipeline growth by identifying, engaging, and qualifying leads. This role is one of the first touchpoints for prospects, and it has the opportunity to set the tone for the sales cycle that follows. · Take the lead in outbound prospect ...