Regulatory Affairs Associate Manager

**Regulatory Affairs Labeling (Senior) Associate (f/m/d), Schaftenau, Tyrol, Austria** 8! That is the number of biosimilars for which Sandoz has already received marketing authorization, and that has provided increased access to life-saving medicines to patients worldwide while further biosimilars are under development. As a Regulatory Affairs Labeling...

**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...

**Manager Regulatory Affairs (f/m/d), Schaftenau/Kundl, Tyrol, Austria** 8! This is the number of high-quality biosimilars for which Sandoz has already received a marketing authorization, and that provided increased access to life-saving medicines to patients worldwide. Additionally, Sandoz has a rich pipeline of further biosimilars under development.**Your...

**RA CMC Associate Director (M/F/d) - Biosimilars, Global Drug Development, Schaftenau, Austria** **582!** 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...

**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 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 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...

**Regulatory CMC Director (f/m/d) - Biosimilars, Global Drug Development, 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 senior member of our Global Regulatory...

**Summary**: LOCATION: Schaftenau, TYPE: Hybrid Working, #LI Hybrid Are you looking for a challenging and rewarding career in Combination Product Development with a brand new device ? Do you want to be part of a team of talented and passionate engineers and scientists who are responsible for the development of parenteral combination products to ensure that...

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. - In this Administrative Assistant (M/F/d) position in our department Regulatory Affairs, Sandoz Biopharmaceuticals you...

We are looking for an Associate Director of Analytical Development Program Management to join 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 to join our teams in...

**RA CMC Submission Coordinator (f/m/d), Schaftenau, Tyrol, Austria** 582! 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, your role would...

**RA CMC Submission Coordinator (f/m/d) - temporary for 2 years, Global Drug Development, Schaftenau, Austria** 582! 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...

**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...

**RA CMC Submission Coordinator - Biosimilars (M/F/d), Global Drug Development, Schaftenau, Austria** **582!** 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 pa-tients’ lives and we need your support. As a member of our Global...

**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**: 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...