Lavoro Regulatory affairs Rotkreuz, Risch, ZG

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... 

Das sind deine Aufgaben: Du verantwortest regulatorische Fragestellungen rund um Energie und verfolgst die politische und regulatorische Entwicklung Aus deinen Analysen leitest du Handlungsempfehlungen ab, erstellst Risikobewertungen, unterstützt die Strategiedefinition...

 ...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... 

 ...Reporting) • Managing project related interactions with Development, Global Platform Support, Design Quality Assurance, Regulatory, Medical Affairs, external suppliers and other internal departments. • Information gathering from respective stakeholders including consolidation... 

 ...Reporting) Managing project related interactions with Development, Global Platform Support, Design Quality Assurance, Regulatory, Medical Affairs, external suppliers and other internal departments. Information gathering from respective stakeholders including consolidation... 

 ...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... 

 ...processes to prepare for and manage internal audits and health authority inspections of all Biogen Affiliates, Global Safety and Regulatory Affairs functions. Manage the global audit and inspection readiness program for Global Safety and Regulatory functions, including... 

 ...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)... 

 ...Minuting internal governance meetings (including investment and risk matters) including circulating agenda and supporting documents Regulatory filings: support the regular filing of regulatory documents and similar ongoing obligations including managing governance... 

 ...Quality and Safety Standards Be knowledgeable and a subject matter expert in both MSD’s internal engineering standards and in country regulatory requirements. Project Management Project execution and oversight to ensure compliance with procurement policies and... 

 ...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... 

 ...next steps, and mitigation. Oversee process interdependencies across the End-to-End Supply Chain and collaborates with Planning, Regulatory Sciences, and Regulatory CMC to ensure that change control and labeling changes align with the FG & DP supply plans, while... 

 ...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... 

 ...Excellent quantitative skills and meticulous attention to details - Strong communication abilities and teamwork skills - Knowledge of regulatory frameworks related to cryptocurrency trading is advantageous By applying for this position, I consent to the Swisslinx Group... 

 ...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 Work with sites to... 

 ...LIMS, SDMS, and LES solutions. Customize the system to meet the specific needs of the organization. Ensure compliance with regulatory standards (GxP, FDA, etc.) throughout the implementation process. Change Management: Develop and execute change management... 

 ...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...