Regulatory Affairs Kaiseraugst AG Jobs

 ...industry and the academic sphere. Job Description One of Sobi’s four strategic pillars is to “Go Global”. The Manager, Regulatory Affairs International supports our ambitious geographical expansion plans. Sobi is seeking to register some of our existing portfolio... 

 ...Ergänzung für unser Team suchen wir per sofort oder nach Vereinbarung eine motivierte Persönlichkeit als Mitarbeiter:in Drug Regulatory Affairs, 80 - 100% (w/m/d) Helfen Sie uns, Arzneimittel für die integrative Onkologie auf den Markt zu bringen, indem Sie, dank... 

Job Purpose Be a member of product development project-teams from the initiation phase, ensure implementation of quality and Regulatory Affairs requirements for Europe, US & Canada, perform product registration in EU, US & Canada.    Main Tasks and Responsibilities... 

 ...compliance with regulations throughout product development. - Conduct regulatory research and prepare documentation for submissions. - Support...  ...- Bachelor's degree in a relevant field. - Prior regulatory affairs experience - general pharma knowledge Ausbildung Regulatory... 

Senior Consultant Regulatory Affairs MedTech (SaMD, AI, Robotics) Compliance Services - Basel, Frankfurt Apply now About Arcondis Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries. Headquartered... 

Ihre Aufgaben ~Mitarbeit bei der Erstellung, Einreichung und Dokumentation des regulatorischen Meldewesen EU (CoRep, FinRep, LiqRep und weitere Unterlagen gemäss Konzernvorgaben) inkl. notwendigem KnowHow Aufbau zur Betreuung der relevanten EDV-Systeme und Schnittstellen...

Job Title: Event Manager Clinical Development & Medical Affairs Work Location: Allschwil Country: Switzerland Schedule: Parttime (80%) Desired start date: ASAP Duration: 12 months Contractor Rate: CHF 69.49 - CHF 77.96 RESPONSIBILITIES AND TASKS • Plan, coordinate... 

 ...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... 

 ...performance indicators related to operational efficiency. Regulatory Compliance ~Ensure that all global manufacturing processes comply...  ...standards including GMP. ~Collaborate with regulatory affairs teams to navigate regulatory requirements and obtain necessary... 

 ...: #1 reducing COGS, #2. establishing a customer obsessed E2E SC, #3 increasing our competitive advantage through Quality and Regulatory affairs, #4 building capacity to support the growth, #5 delivering on the group’s ESG commitments, by #6 engaging and growing people,... 

 ...oriented and analytical mindset; ability to identify potential deficiencies, propose solutions, and effectively interpret and apply regulatory requirements; excellent communication skills; ability to collaborate efficiently with interdisciplinary teams in a dynamic... 

 ...on budget) Establish and oversee the execution of robust integrated drug development plans that are patient focused and address regulatory commercial and access considerations Drive decisionmaking for budget and resource commitments. Ensure the consideration of... 

 ...Study Conduct: Conduct release, retest, stability studies, transfer, and validation analyses in compliance with GMP and regulatory guidelines. Data Interpretation: Interpret and document analytical data from various stages including method development... 

 ...Bachelor degree preferred in a technical field and/or engineering. Proven process understanding in Sterile Manufacturing (Pharma, regulatory aspects). Familiarity with GMP requirements, quality procedures and SOP execution. Previous exposure to any of the... 

 ...aktive Mitarbeit in bereichsübergreifenden Prozessen vertreten Sie an den Schnittstellen zwischen Produktion, Qualitätssicherung, Regulatory Affairs und R&D die Interessen aller Seiten. Sie erstellen die eigenen Dokumente fristgerecht und qualitativ hochwertig und... 

 ...managing tests for the software they build. Process & Operations: support test automation required by quality practices as well as regulatory compliance needs. Fluent in English If its an interest to you then please reply asap as we have a deadline to submit the... 

 ...with internal teams to ensure timely release of GMP relevant documents and batches. Upholding compliance with cGMP guidelines, regulatory requirements, and internal SOPs.   Why Join Us?   Location: Fully site-based in Basel, Switzerland, immerse yourself in a... 

 ...Study Conduct: Conduct release, retest, stability studies, transfer, and (pre-) validation analyses in adherence to regulatory standards. Documentation: Write and review analytical method protocols, reports, and ensure comprehensive documentation... 

 ...g. DHL, World Courier), IT & Digital teams, the wider PTDS network, Clinical Operations customers and stakeholders, Quality, and Regulatory. This role is part of a broader chapter which applies the role based working concept. The key responsibilities mentioned below are... 

 ...activities in fresh markets, documenting them comprehensively Monitor and analyse forthcoming and recently enacted tax laws, regulatory positions, legal rulings, and court cases impacting the company's direct tax position. Propose strategic action steps as required...