Drug regulatory Zug 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 im Rahmen der Strom- und Gasversorgungsgesetzgebung und verfolgst die politische und regulatorische Entwicklung Aus deinen Analysen leitest du Handlungsempfehlungen ab, erstellst Risikobewertungen...

 ...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 manufacturing... 

 ...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... 

 ...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... 

 ...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... 

 ...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... 

 ...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)... 

 ...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... 

 ...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... 

 ...biomarker or In Vitro Diagnostic development ~ Experience in companion diagnostic development, analytical and clinical validations and regulatory submissions or instrument development and program management is a plus ~ Experience in a regulated industry (e.g. FDA 21 CFR... 

 ...Software 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 (verification... 

 ...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... 

 ...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... 

 ...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...