Regulatory Officer
vor 4 Wochen
Company Description PSI is a leading Contract Research Organization with almost 30 years on the market, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Regulatory OfficerMunich, Germany I Full-time Job Description Join our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career. Office-based in Munich/Planegg Your role: Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities, including Import and Export license applications Communicate with regulatory authorities, ethics committees, project teams and vendors on regulatory-related matters Review translations of essential documents subject to clinical trial submission Track the regulatory project documentation flow Review documents to greenlight IP release to sites Manage safety reporting to authorities Deliver regulatory training to project teams Assist with feasibility research and business development requests Qualifications College/University degree or an equivalent combination of education, training and experience Prior experience with clinical trial submissions in Germany Full working proficiency in English and German Proficiency in MS Office applications Detail-oriented Ability to learn, plan and work in a dynamic team environment Communication, collaboration, and problem-solving skills Additional Information We offer: Excellent and flexible working conditions Extensive training and friendly, collegial team Competitive salary and benefits package Opportunities for personal and professional growth If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you. I'm interested
-
Regulatory Compliance Officer
vor 13 Stunden
Munich, Deutschland Schulz & Cie. Consulting GmbH VollzeitAufgabengebiet im S+P Compliance Team - Regulatory Monitoring, - Assessment zu aufsichtsrechtlichen Änderungen, - Durchführung von Risk Assessments, - Mitarbeit an Fachkonzepten zur Umsetzung regulatorischer Neuerungen sowie - Bestellung als Compliance Officer Branche - Finanzunternehmen - Banken - Wertpapierdienstleister -...
-
Regulatory Compliance Officer
Vor 6 Tagen
Munich, Deutschland Schulz & Cie. Consulting GmbH VollzeitAufgabengebiet im S+P Compliance Team - Regulatory Monitoring, - Assessment zu aufsichtsrechtlichen Änderungen, - Durchführung von Risk Assessments, - Mitarbeit an Fachkonzepten zur Umsetzung regulatorischer Neuerungen sowie - Bestellung als Compliance Officer Branche - Finanzunternehmen - Banken - Wertpapierdienstleister -...
-
Finance Regulatory Reporting, Officer
vor 1 Woche
Munich, Deutschland State Street VollzeitWhy this role is important to us You will be joining the Regulatory Reporting team in Global Finance Center Krakow (Poland), which provides a wide range of complex financial and reporting services. The team gives senior stakeholders financial tools and information they need to make an effective analyzes and transparent reporting to multiple State Street...
-
Traineeprogramm: Business Development
Vor 4 Tagen
Munich, Deutschland Pivot Regulatory GmbH VollzeitPIVOT Regulatory ist eine Strategieberatung für Unternehmen im Spannungsfeld von Politik und Gesellschaft, die auf Zahlen, Daten und Fakten gründet. Basierend auf wissenschaftlichen Erkenntnissen entwickeln wir politische Strategien für Kunden aus stark regulierten Branchen, insbesondere aus dem Gesundheits - und Konsumgüterbereich. Wir bewerten die...
-
Working Student in Regulatory Affairs
vor 2 Wochen
Munich, Deutschland Brainlab VollzeitCompany Description Founded in Munich, Germany in 1989, Brainlab develops, manufactures and markets software-driven medical technology, enabling access to improved, more efficient, less-invasive patient treatments. Our key to success is our creative, talented and hard-working team, which consists of 1400 dedicated and inspiring individuals in 19 offices...
-
Working Student
Vor 3 Tagen
Munich, Deutschland Brainlab VollzeitCompany Description Founded in Munich, Germany in 1989, Brainlab develops, manufactures and markets software-driven medical technology, enabling access to improved, more efficient, less-invasive patient treatments. Our key to success is our creative, talented and hard-working team, which consists of around 2000 dedicated and inspiring individuals in 25...
-
Senior Regulatory-Toxicologist
Vor 3 Tagen
Munich, Bayern, Deutschland Ramboll Vollzeit 60.000 € - 90.000 € pro JahrJob Description We invite you to become part of our Health Sciences team and bring your expertise into play part of our international team. To succeed in this role, technical expertise in human health risk assessment and a good understanding of national and EU legislations related to industrial chemicals, biocides and consumer products is required. Are you...
-
Experienced Regulatory Submissions
vor 4 Wochen
Munich, Deutschland Medpace VollzeitMedpace OverviewMedpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We...
-
Experienced Regulatory Submissions
vor 2 Wochen
Munich, Deutschland Medpace VollzeitMedpace OverviewMedpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We...
-
Head of Regulatory and Quality
vor 1 Woche
Munich, Bayern, Deutschland Amplifold Vollzeit 60.000 € - 120.000 € pro JahrAbout usAmplifold is pioneering the next generation of molecular diagnostics through breakthrough molecular design and DNA nanotechnology. By reimagining how biomolecules are assembled and interact, we are unlocking new levels of precision, speed, and sensitivity in immunoassays and related diagnostic platforms.We are a small, ambitious team of scientists...
