Emploi Regulatory affairs Zoug ZG

 ...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... 

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...

 ...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... 

 ...Proficiency in electrical engineering Experience in product development and manufacturing processes. Excellent knowledge of regulatory requirements and standards in the medical device industry. Minimum of 5 years of experience in medical product registration... 

 ...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... 

 ...in analytical tools like Excel, Python, or R - Excellent quantitative skills and meticulous attention to details - Strong communication abilities and teamwork skills - Knowledge of regulatory frameworks related to cryptocurrency trading is advantageous... 

 ...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... 

 ...Produktstrategie ist der Medical Advisor verantwortlich für die Unterstützung der Konzeption, Umsetzung und Ausführung von Medical Affairs-Plänen für den zugewiesenen Therapiebereich, die Bereitstellung wissenschaftlicher Informationen, die Unterstützung bei der Gestaltung... 

 ...motivation est de faciliter le travail de nos clients avec nos produits et nos services «just in time». Les petites quantités sont notre affaire. Les approches innovantes en atière de services sont notre élan. Gyr Métaux précieux SA est le leader du marché suisse dans le... 

 ...mandatés Evaluation de biens immobiliers Représentation de Swiss Life Immopulse dans le secteur immobilier Transmission d'affaires de prévoyance et d'hypothèques (vente croisée) Vos atouts Une longue expérience dans la transmission immobilière en... 

 ...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... 

 ...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... 

 ...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... 

 ...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... 

 ...bridge financing provider, annual statements to funds' Swiss Representative # Support in delivery of investor-level & fund tax and regulatory reporting/filing with third-party service providers # Manage and ensure accuracy of fund vehicle data transfers between service... 

 ...risk management, to drive innovation and enhance trading capabilities. - Maintain up-to-date knowledge of market conditions, regulatory changes, and technological advancements in agricultural commodities trading. - Communicate effectively with management and stakeholders... 

 ...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.... 

 ...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 (... 

 ...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... 

 ...company projects and programs across the different locations of the KLK Kolb Group (CH, NL) Ensure that implemented solutions meet regulatory and contractual requirements Collaborate with internal stakeholders to define and document project scope, deliverables and...