Lavoro Drug regulatory Baar ZG

 ...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... 

 ...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 are not... 

 ...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... 

 ...working practices within the matrix structure. Support the regulatory teams, Market Access and Reimbursement activities in the EPM markets...  ...Doctor degree is mandatory. Proficient in all aspects of drug development, GCP and regional regulations - including the... 

 ...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... 

 ...curiosity meets purpose Neuroscience Connecting the dots in neuroscience Science & Innovation Multiple modalities in drug development See all Stories Disease Areas We believe no other disease area holds as much need or promise for medical... 

 ...interested in Responsibility Increasing diversity in clinical trials: A collaboration with Tufts Center for the Study of Drug Development Multiple Sclerosis The hidden face of MS Lupus Living with lupus: Hazura’s story 2021 Year in... 

 ...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... 

 ...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... 

 ...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... 

 ...instructors and other volunteers who make sure the Community Lab continues to make an impact. Jorge Sanchez-Salazar, a scientist in Biologics Drug Discovery and a Community Lab volunteer, works at Biogen because of the people and the students he gets to help. Students often... 

 ...external 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... 

 ...for 20 years on the commercial side of Biogen’s business bringing drugs to patients. "My mom touched everything in the pipeline by...  ...Dolnikova-Smith said. All told, they have worked on almost every drug therapy that has come through Biogen’s pipeline, impacting millions... 

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... 

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...

 ...modernsten Dienstleistungen ein wirklich persönliches Kundenerlebnis schaffen. Ihr Aufgabengebiet Als IT Business Analyst Regulatory & Investment Compliance arbeiten Sie an der Schnittstelle zwischen der Bank und der IT. In dieser abwechslungsreichen und verantwortungsvollen... 

 ...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... 

 ...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... 

 ...classification under applicable law. Thomson Reuters is proud to be an Equal Employment Opportunity/Affirmative Action Employer providing a drug-free workplace. We also make reasonable accommodations for qualified individuals with disabilities and for sincerely held... 

 ...inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. Enabled by our proprietary drug discovery platform, Deciphera has developed a diverse pipeline of wholly-owned drug candidates. QINLOCK® (ripretinib) is Deciphera’s... 

 ...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... 

 ...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... 

 ...generate innovative solutions. ~Troubleshoot and resolve interdisciplinary issues. ~Ensure adherence to Tecan's processes and regulatory requirements. ~Contribute to the achievement of project goals.   Your Background We’re not just looking for hard skills: 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,... 

 ...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... 

 ...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... 

 ...communicate trading insights and strategies with the broader team. Collaborate with the compliance team to ensure adherence to regulatory requirements. Requirements Requirements: Bachelors degree in Finance Economics Mathematics or a related field OR... 

 ...and Fintech Create assess and negotiate contracts policies and various legal documentation Manage and execute requests from regulatory authorities Offer insights on legal and regulatory prerequisites for financial products and services Provide legal guidance...