Emploi Drug regulatory Zoug ZG

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...

 ...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... 

 ...Description About the role: The Senior Director, Global Regulatory Strategy, Therapeutic Area Lead in Global Regulatory Affairs is...  ...of regulatory submissions including Investigational New Drug (IND) and New Drug Applications (NDA)/centralized Marketing Authorization... 

 ...Act as Responsible Person (RP) delegate for Commercial Biologics Drug Substances (DS), Parenteral Drug Products (DP), Parenteral...  ...compliance. Experience in clinical products manufacturing and/or regulatory is an asset. Knowledge of medical device regulations and manufacturing... 

 ...portfolio of innovative medicines. Enabled by our proprietary drug discovery platform, Deciphera has developed a diverse pipeline...  ...within the UK. Provide medical expertise in all regulatory, early access and reimbursement approval processes. Partner... 

 ...and Artwork for commercial products. Monitoring changes to Drug Substance (DS) and Drug Product (DP) in global change management...  ...across the End-to-End Supply Chain and collaborating with Planning, Regulatory Sciences, and Regulatory CMC. Developing and implementing... 

 ...accountabilities, for providing hands-on legal commercial support to medmix Drug Delivery business segment and provide corporate and governance...  ..., including preparing the Annual General Meeting, address regulatory aspects of Swiss listed companies. ~ Demonstrated ability to... 

 ...assessments Possess and maintain knowledge of current global GMP regulatory requirements and industry trends to ensure compliance at...  ...is preferable. At least 5 years of experience working with drug substance/drug product manufacturing, Quality Control and/or Quality... 

 ...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... 

 ...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 Coordinate... 

 ...Engineer III will be leading, facilitating, or coordinating all activities pertaining to tech transfer within the Switzerland internal drug substance manufacturing site. Also, this person will lead technology transfer assignment and prioritization for drug product... 

 ...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... 

 ...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... 

 ...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... 

 ...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... 

 ...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... 

 ...market trends, have a close eye on our competitor landscape, and implement the necessary measures. You coordinate actions to fulfill regulatory requirements. You actively participate in maintaining and revising the product portfolio allocation to our production plants,... 

 ...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...