Regulatory Affairs Risch ZG Jobs

 ...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...

 ...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... 

 ...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... 

 ...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... 

 ...clinical trial requires careful consideration. In most cases, the therapies investigated in clinical trials are not yet approved by regulatory agencies like the Food and Drug Administration (FDA) in the United States. The benefits and risks of taking investigational drugs... 

 ...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... 

 ...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... 

 ...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... 

 ...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... 

 ...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... 

 ...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... 

 ...as analyzing our performance, meeting our legal obligations, developing our workforce, reporting on adverse events, monitor our regulatory compliance, and other analysis of our programs and services). We may use Consumer Health Data for other purposes for which we... 

 ...digitization cloud computing IoT FinTech and LegalTech Handle legal matters related to contract law data protection law copyright law regulatory compliance and other businessrelated legal areas like corporate law debt enforcement and bankruptcy law and antitrust or... 

 ...Entwicklung, Herstellung, Prüfung und Qualitätssicherung von Arzneimitteln und / bzw. Erfahrung mit Arzneimittelzulassung / Regulatory Affairs von Vorteil GMP-/GDP-Kenntnisse in der pharmazeutischen Industrie Kenntnisse im nationalen und internationalen pharmazeutischen...