Lavoro Regulatory affairs Basilea BS

 ...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... 

 ...Switzerland. Job Description Do you have a Master degree or a PhD in Science? Are you looking to grow a new career in the Regulatory field? If so, we have a fantastic and unique opportunity to join Syngenta Global Regulatory Team based in Basel. You will take an... 

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...

 ...Biologie Mehrere Jahre Erfahrung in einer ähnlichen Funktion, v.a. im Medical Clearing, Medical Marketing Erfahrung als Medical Affairs Manager, Medical Manager, Medical Science Liasion Erfahrung in der Erstellung von wissenschaftlichen Dokumenten und Kenntnisse... 

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... 

 ...career opportunities and offer the latest in skill development training programmes. Event Manager Clinical Development and Medical Affairs 80% Our client is a pioneer in Drug Discovery and Development and one of the frontrunners in Personalised Healthcare. As the world... 

Summary The Regulatory Affairs Postgraduate Training Program is an opportunity to discover the global functions of Regulatory Affairs and Regulatory Chemistry, Manufacturing and Controls. Successful candidates will be offered a training position consisting of two rotational... 

 ...parameters and correlations to optimize method performance. 6) Regulatory Compliance : Ensure compliance with regulatory requirements...  ...& DP process development, quality assurance, and regulatory affairs, to align method development activities with organizational goals... 

 ...collaborate closely with Global HEOR Asset Leads and CoEs, as well as Global/International/Country Medical Affairs, Market Access, Pricing, Commercial, Regulatory, and other stakeholders. Moreover, you will work with external stakeholders to support reimbursement submissions... 

 ...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... 

 ...SOPs, Change Control, Discrepancy Management, CAPA (corrective action and preventive action), Risk Analysis Assist management in regulatory inspections and performing internal as well as partner audits Ensure adherence to cGMP requirements and Roche policies and... 

 ...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... 

 ...sharing and collaboration. # Risk Management: Identify and mitigate e-mobility-specific risks, such as battery limitations and regulatory uncertainties, to ensure project success. # Budget Control: Monitor project budgets and resource allocations, optimizing cost-... 

 ...strategy in clinical programs. Contribute to the clinical development plan. Responsible for clinical pharmacology sections in regulatory documents and at interactions with regulatory authorities during all phases of drug development.  Represent clinical...