Regulatory Affairs Cmc Manager

**Summary**: **About the Role**: **Major accountabilities**: - Formulate, lead and drive global CMC regulatory strategy with a focus on innovation, balancing business benefit with regulatory compliance for XXX modality projects/products. - Lead and implement global CMC submission activities (planning, authoring, reviewing, coordination, submission) for...

**Summary**: **About the Role**: **Major accountabilities**: - Formulate, lead and drive global CMC regulatory strategy for XXX modality pro-jects/products drawing on substantial regulatory expertise with a focus on innovation, maxim-izing the business benefit balanced with regulatory risks and compliance. - Identify the required documentation and any...

**Summary**: Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people’s lives. To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and platform depth and capabilities - all to bring our medicines to patients...

**Summary**: Supporting product registration and maintenance throughout the product life cycle by aligning regulatory strategies and reviewing documents related to CMC (Chemistry, Manufacturing & Control). This applies to site specific (global and local) products and is intended to ensure timely market supply in compliance with regulatory requirements....

**Summary**: Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people’s lives. To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and platform depth and capabilities - all to bring our medicines to patients...

**Summary**: Verantwortlich für regulatorische Aktivitäten insbesondere in den Bereichen Chemie, Herstellung und Kontrolle (CMC). Aktivitäten wie die Vorbereitung und Veröffentlichung von REG CMC-Dokumentation für Einreichungen bei Gesundheitsbehörden. Interagieren Sie außerdem mit HA's auf REG CMC-Fragen, um neue Produkte oder Markteinführungen zu...

**Summary**: **About the Role**: **Major accountabilities**: - You will support the global Medical Device & Precision Medicine regulatory strategy with a focus on innovation, maximizing business benefit balanced with regulatory compliance. - Lead, support and implement all global Regulatory Affairs Medical Device (RA MD) submission activities for assigned...

**Summary**: **About the Role**: **Major accountabilities**: - You will support the global Medical Device & Precision Medicine regulatory strategy with a focus on innovation, maximizing business benefit balanced with regulatory compliance. - Lead, support and implement all global Regulatory Affairs Medical Device (RA MD) submission activities for assigned...

**Summary**: As Senior QA Compliance Expert you will support, facilitate and drive on-site regulatory CMC related launch and post-approval activities (post-approval changes, transfers, remediation, divestment, pruning and due diligence) of the Campus products to ensure timely supply to the markets in compliance with current regulatory obligations and...

**Summary**: About the role The Associate Technical Project Leader will, jointly with the CMC team, lead and manage all technical development activities for assigned projects ranging from small molecules to large molecules within Technical Research & Development (TRD); represent TRD as core member in global project teams to define the global CMC strategy for...

**Summary**: About the role The Associate Technical Project Leader will, jointly with the CMC team, lead and manage all technical development activities for assigned projects ranging from small molecules to large molecules within Technical Research & Development (TRD); represent TRD as core member in global project teams to define the global CMC strategy for...

394430BR **Technical Project Leader - f/m/d**: Austria **About the role** At Novartis, we don't just create life-changing medicines. We build partnerships and empower communities to help to make healthcare more accessible for all. There’s no limit to what we can achieve for patients when we challenge ideas and champion individuals. Our work feels most...

**Summary**: About the role At Novartis, we don't just create life-changing medicines. We build partnerships and empower communities to help to make healthcare more accessible for all. There’s no limit to what we can achieve for patients when we challenge ideas and champion individuals. Our work feels most rewarding when we stretch ourselves with the full...

**Summary**: Analytical Project Lead, LOCATION: Schaftenau, Austria or Mengeš, Slovenia, #LI-Hybrid We are a global team of highly skilled analytical project managers with presence in all biologics technical research and development sites of Novartis in Europe. We are looking for you as an experienced, curious, inspiring Analytical Project Leader (APL) to...

394730BR **Senior Expert - Device Project Analyst (f/m/d)**: Austria **About the role** **Location: Schaftenau, Austria, Hybrid Working #LI-Hybrid** **About the Role**: **Key Responsibilities**: Your responsibilities include, but are not limited to: - As member of global CMC analytical sub team and device sub team for your project(s) you are contact...

**Summary**: **About the Role**: **Key Responsibilities**: Your responsibilities include, but are not limited to: - As member of global CMC analytical sub team and device sub team for your project(s) you are contact person & coordinator for all project-specific analytical tasks related to functional attributes of drug-device combination products at all...

**Summary**: ~Management-Spur Dies ist eine universelle Stellenbeschreibung, die einige der primären Aufgaben dieser Rolle erfassen soll, die in allen Funktionen oder Abteilungen üblich sind. Es ist nicht beabsichtigt, alle spezifischen Verantwortlichkeiten der Position zu repräsentieren. Leitung einer Funktion für die Entwicklung von...

**Summary**: The Supply Chain Manager (SCM) is responsible for Demand and Supply Planning from Clinical Finished Good (CFG) to Drug Substance (DS) ensuring demand fulfilment for assigned projects. The SCM acts as key contributor to the Clinical Supply & Operations Planning (CS&OP) process in Technical Research & Development (TRD)/GCS and provides...

**Summary**: **About the Role**: **Key Responsibilities**: - Creates and maintains the end-to-end supply plan from CFG to DS - Harmonizes the supply strategy within GCS and contributes to the supply strategy of CHAD/PHAD/Biologics - Leads the Clinical Demand Planning Meeting (CDPM) ensuring alignment between demand and supply - Ensures demand fulfillment...

**Summary**: **About the Role**: **Key Responsibilities**: - Creates and maintains the end-to-end supply plan from CFG to DS - Harmonizes the supply strategy within GCS and contributes to the supply strategy of CHemical and Analytical Development/ PHArmaceutical Development (CHAD/PHAD)/Biologics - Leads the Clinical Demand Planning Meeting (CDPM) ensuring...