Regulatory Affairs Manager

**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: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 projects/products,...

Regulatory Affairs Associate (m/w/d) - 8! This is the number of biosimilars for which Sandoz has already received a marketing authorization, and that already provided increased access to life-saving medicines to patients worldwide while further biosimilars are under development. - As a Regulatory Affairs Associate (M/F/d) you contribute to bringing new...

Regulatory Affairs Associate (m/w/d) 8 This is the number of biosimilars for which Sandoz has already received a marketing authorization, and that already provided increased access to lifesaving medicines to patients worldwide while further biosimilars are under development. As a Regulatory Affairs Associate (M/F/d) you contribute to bringing new biosimilars...

**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 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 required documentation...

**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 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 assigned...

**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:About the Role:Major accountabilities: Formulate, lead and drive global CMC regulatory strategy for XXX modality projects/products drawing on substantial regulatory expertise with a focus on innovation, maximizing the business benefit balanced with regulatory risks and compliance. Identify the required documentation and any content, quality and/or...

**RA CMC Associate Director (M/F/d) - Biosimilars, Novartis, Schaftenau, Austria** 583! That is the total number of projects and products on our Global Regulatory Affairs CMC project list. All of these innovative projects are aimed at making a difference in patients’ lives and we need your support. - As a member of our Global Regulatory Affairs CMC team,...

**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...

At Novartis, we are reimagining medicine to improve and extend people's lives. We discover and develop breakthrough treatments and find new ways to bring cures to as many people as possible. Without safe, easy-to-use, high-quality drug delivery systems our patients could not get their medicines. This is where you come in - the Device Technology Solution...

We are the first company to achieve the EU Medical Device Regulation (EU MDR) certification. Medical device certifications are important enablers to product launches and continued market access (LCM). Creativity and innovative mindset are key assets as regulatory framework is increasing in complexity, as well as new medical device certifications are about to...

**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...

**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...

**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 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 CHAD/PHAD/Biologics - Leads the Clinical Demand Planning Meeting (CDPM) ensuring alignment between demand and supply - Ensures demand fulfillment...