Regulatory Affairs CMC Senior Manager

About the RoleAs a key member of our Development Team, you will play a critical role in shaping our global CMC regulatory strategy for Biologics or Small Molecules projects/products. With a strong background in regulatory affairs and a focus on innovation, you will be responsible for formulating and driving global CMC regulatory strategies that maximize...

**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 and lead global CMC regulatory strategy with a focus on innovation, balancing business benefit with regulatory compliance. - Lead and implement global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. - Identify the...

**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**: 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**: 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**: **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...

About the RoleWe are seeking a highly experienced Senior Project Manager to lead the creation of strong analytical data-packages for drug-device combination products. As the main contact and coordinator for all project-specific analytical tasks, you will be responsible for planning resources and budget, and authoring respective analytical documents.Key...

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**: 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...

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**: - 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**: 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...

**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**: **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...

Job SummaryWe are seeking a highly skilled Senior Process Expert to join our team at Novartis. As a key member of our Process Support Unit, you will provide technical expertise and support to ensure the smooth execution of processes and compliance with regulatory requirements.Key ResponsibilitiesProvide front-line technical support for process-specific...

Location: Austria, SchaftenauAs a Senior Process Expert, you will deliver essential technical and scientific expertise for all process-related challenges to guarantee timely execution of operations (business continuity); ensuring adherence to cGMPs, SOPs, and relevant guidelines and functional standards (e.g., HSE, NOSSCE) while continuously enhancing...