Regulatory Affairs Rotkreuz, Risch, ZG Jobs

Das sind deine Aufgaben: Du verantwortest regulatorische Fragestellungen im Rahmen der Strom- und Gasversorgungsgesetzgebung und verfolgst die politische und regulatorische Entwicklung Aus deinen Analysen leitest du Handlungsempfehlungen ab, erstellst Risikobewertungen...

 ...About the role As Regulatory Affairs Manager, you will be responsible for all drug regulatory affairs matters for the assigned indication group and will act as an interface between global Regulatory Affairs departments and Swissmedic to obtain new marketing authorizations... 

 ...motivated, insightful, and resourceful individual to join the Medical Affairs International team. Reporting directly to the Senior Director,...  ...within the UK. Provide medical expertise in all regulatory, early access and reimbursement approval processes. Partner... 

 ...Reporting to the Chief Legal Officer, the Head of Legal Affairs is responsible, among other accountabilities, for providing hands...  ...matters, including preparing the Annual General Meeting, address regulatory aspects of Swiss listed companies. ~ Demonstrated ability to... 

 ...Job Description About the role: The Senior Director, Global Regulatory Strategy, Therapeutic Area Lead in Global Regulatory Affairs is responsible for the development of end-to-end US, Above-Country EU and Global regulatory strategies for assigned programs from... 

 ...the entire EPM Medical region. Reporting to the VP of Medical Affairs, you'll play a key role in the EPM Leadership Team, focusing on...  ...working practices within the matrix structure. Support the regulatory teams, Market Access and Reimbursement activities in the EPM... 

 ...industries Knowledge of Healthcare Compliance Program requirements or experience in other defined governance roles (Audit, GxP, Regulatory Affairs, Business Compliance etc.) Data driven and attention to detail Experience with policy and procedure drafting and... 

 ...stakeholders to support strategy development and execution. Work collaboratively with internal functions such as Medical, Regulatory, Government Affairs & Public Affairs. Operational Expertise and Support: Actively support affiliates in preparing reimbursement... 

 ...management (LCM). The role of the Lifecycle Management(LCM) Strategy Lead - Friedreich’s Ataxia (FA) is to work across R&D, regulatory, medical affairs, commercial, value & access and corporate affairs as part of the Product Development and Commercialization(PDC) team,... 

 ...Solid knowledge of cGMP requirements, EU/FDA regulations and compliance. Experience in clinical products manufacturing and/or regulatory is an asset. Knowledge of medical device regulations and manufacturing is a plus. Ability to develop effective working relationships... 

 ...coordination with the content manager, subject matter experts, and project teams Ensures that quality targets, timelines, and regulatory requirements are respected After translation, creates target language versions of deliverables (in all appropriate formats)... 

 ...advising Operations Planner on label strategy for a clinical packaging job. Reviewing county-specific label text on accuracy and regulatory requirements. Handling of randomization schedules for clinical studies. Reviewing and release of label batch record... 

 ...Responsible for compliance application of the change and the corresponding KPIs Responsible for maintenance and preparation of the regulatory correct documentation, for example Change Request/Change Notification, Design Master Record, Design History File etc Planning... 

 ...and resolve or escalate issues in a timely manner Collect, receive and perform the first review of required study-specific site regulatory/essential documents in accordance with applicable SOPs, guidelines, and study timelines and requirements Coordinate... 

 ...biomarker or In Vitro Diagnostic development ~ Experience in companion diagnostic development, analytical and clinical validations and regulatory submissions or instrument development and program management is a plus ~ Experience in a regulated industry (e.g. FDA 21 CFR... 

 ...Software concepts, architectures and platforms Ensure associated documentation in German or English language according to international regulatory requirements as well as Medela’s development process and medical technology guidelines Design, implement and test (verification... 

 ...advising Operations Planner on label strategy for a clinical packaging job. Reviewing county-specific label text on accuracy and regulatory requirements. Handling of randomization schedules for clinical studies. Reviewing and release of label batch record documents. Ensuring... 

 ...English & German Proficiency in accounting software (Infoniqa) and MS Office (proficient in Excel) Familiarity with GAAP and regulatory requirements and with IFRS experience being highly beneficial Strong attention to detail analytical and able to work on... 

 ...). Sound knowledge of cGMP requirements, EU/FDA regulations and compliance. Experience in clinical products manufacturing and/or regulatory is an asset. Knowledge of medical device regulations and manufacturing is a plus. Ability to develop effective working relationships... 

 ...Vous êtes responsable de la clarification commerciale et technique des demandes des clients. Vous êtes responsable du chiffre d'affaires et de la marge bénéficiaire de votre région. Vous organisez des présentations de produits et des formations directement chez le...