Regulatory Affairs Zentralschweiz 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... 

 ...interested in finding out more? We want you to join us as a/an ... Public Affairs Manager Your responsibilities: The Public Affairs Manager is responsible for, and manages, the political and regulatory dossiers relevant to the company, reporting to the Chief... 

 ...Your responsibilities:The Public Affairs Manager is responsible for, and manages, the political and regulatory dossiers relevant to the company, reporting to the Chief Communications and Public Affairs Officer (CCO). This person is also responsible for the planning, development... 

 ...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... 

Responsibilities Assist the direct front-line customer support teams managing and resolving guest complaints. Especially, handling incoming escalations by taking ownership and following problems through to resolution independently. Assist in the drafting, reviewing...

 ...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... 

 ...promising career opportunities and offer the latest in skill development training programmes. Contract Manager within Global Medical Affairs – 5854 LBD We are looking for a highly motivated Contract Manager within Global Medical Affairs for our client, a major... 

 ...career opportunities and offer the latest in skill development training programmes. Event Manager Clinical Development and Medical Affairs 80% Our client is a pioneer in Drug Discovery and Development and one of the frontrunners in Personalised Healthcare. As the world... 

 ...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... 

 ...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... 

 ...the EHS Lead will work with minimal oversight and will manage regulatory (federal, cantonal, local) and ELC requirements related to safety...  ..., hazardous Materials, machinery Safety, or Environmental Affairs, preferably in manufacturing operations • Preferred certifications... 

 ...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)... 

 ...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... 

 ...Head Finance & Accounting Tasks Manage and oversee the companys financial records ensuring accuracy and compliance with regulatory standards Active and independent preparation in monthly quarterly and annual financial statements in accordance with Swiss Code... 

 ...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... 

 ...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... 

 ...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 (... 

 ...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...