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- ...drugs). Lead / Support development and execution of Phase 3 CMC regulatory strategy Author / Review CMC sections of IND amendments, CTA updates, and BLA/MAA modules Manage / Coordinate responses to health authority CMC questions Lead / Support health authority...ConsigliatoTemporaneo
- ...Sicherstellung der Data-Integrity-Anforderungen im verantworteten Bereich Anforderungen Abgeschlossene Ausbildung als Chemielaborant, CTA oder Chemieingenieur mit mindestens zwei Jahren Erfahrung im GMP-Umfeld Sehr gute Kenntnisse in der instrumentellen Analytik,...Consigliato
- ...supervisor Contribute to Ethics Committee/IRB application submissions and prepare required documentation in collaboration with the CTA and as directed by the Lead CRA/Project Manager Participate in contract handling and negotiation under direction of the Lead CRA/...ConsigliatoFreelanceRemote job
- ...Telefonzentrale und Empfang Ihr Profil Abgeschlossene Ausbildung als Chemielaborant*in oder Chemisch-technische Assistent*in (CTA) mit Interesse an kaufmännischen Arbeiten Idealerweise Berufserfahrung in einer ähnlichen Position oder im Analytiklabor Gute...ConsigliatoSostituzioneLavoro festivoTempo indeterminatoOrario flessibile
- ...GDT/LCT ensuring appropriate data are reflected in the protocol ICFs and CSR. You will establish the clinical science strategy for CTA/EC submissions briefing packs and responses to HA questions and provide context with respect to the broader CDP to the filing team...Consigliato
- ...partnership opportunities. Documentation & Communication Prepare study reports, presentations, and regulatory documents (e.g., IND, CTA). Present findings to internal stakeholders and external collaborators as needed. Team Leadership: Lead and mentor a team...Consigliato
- ...Integrity (z. B. Audit‑Trail‑Reviews) Profil Abgeschlossene berufliche Ausbildung als Chemielaborant/in, Chemieingenieur/in oder CTA mit mind. 2 Jahren Erfahrung im GMP‑Umfeld Sehr gute Kenntnisse in instrumenteller Analytik, insbesondere HPLC Vertraut mit USP...ConsigliatoTemporaneo
- ...guidelines as needed to support global programs. Ensures conformance to commitments made with various regulatory agencies (e.g. IND/CTA commitments) for assigned programs. Provides regulatory advice to other functional areas. May participate in regulatory due...ConsigliatoTempo pieno
- ...Datenintegrität im eigenen Verantwortungsbereich Ihr Profil Abgeschlossene Ausbildung als Chemielaborant:in, Chemieingenieur:in oder CTA mit mindestens zwei Jahren Berufserfahrung im GMP-Umfeld Sehr gute Kenntnisse in der instrumentellen Analytik (HPLC, GC,...ConsigliatoTempo determinato
- ...multidisciplinary meetings with health addition you will be a key point of contact for one (or more) regulatory capability area(s) (e.g. CTA NDA LCM data management systems) and drive efficiency and excellence in this area. You will serve as the voice of the organization...ConsigliatoTempo pieno
- ...fluent German. French or Italian is advantageous ~12+ months' in a similar role either within industry or academia (we can review CTA/In-House CRA profiles) What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it...ConsigliatoLavoro da remotoAttività autonoma
- ...working collaboratively with interdisciplinary teams. As the icing on the cake you bring along A Certified Technical Architect (CTA) credential or other advanced Salesforce architecture certifications. Experience with GxP regulatory compliance and document or...ConsigliatoTempo pieno
- ...devices • Global regulatory strategy development across EU, US, and Swiss regulatory frameworks • Clinical trial authorisation (CTA) preparation and regulatory interaction management • Post-market surveillance and pharmacovigilance regulatory compliance •...ConsigliatoTemporaneoTempo determinato
- ...Ausbildung zum Feinmechaniker oder staatl. gepr. Techniker der Fachrichtungen Maschinenbau Chemie Chemielaborant oder vergleichbar (z.B. CTA) Kenntnisse in den Bereichen analytische Messtechnik (vorzugsweise HPLC) sind von Vorteil alternativ Erfahrung aus dem Bereich...ConsigliatoTempo pienoLavoro festivo
- ...changes in U.S. tax legislation relevant to asset managers operating offshore Qualifications: CPA (U.S.) EA (Enrolled Agent) CTA (UK) ACA or LL.M. in Taxation Minimum of 212 years of relevant U.S. tax experience ideally within a Big 4 mid-tier or in-house...ConsigliatoTempo pieno
- ...diseases or antibacterial drug development is an asset. Strong understanding of GCP, trial conduct, and regulatory standards (IND, CTA). Fluent in English; additional languages are an advantage. Proactive, curious, and adaptable personality, eager to work...
- ...effectively such as Late Stage Technical Development Committee (LSTDC). Ensure timely and efficient delivery of CMC packages supporting IND CTA IMA/BLA/NDA and global submissions. Drive portfolio insight and performance analytics to optimize resource allocation and...Tempo pienoLavoro urgente
- ...implementappropriate regulatorystrategies to mitigate risks. # Manage or support the preparation and submission of regulatory applications (CTA MAA etc.) and any post-marketing commitments and maintenance. Develop and/or review regulatory documents to ensure that all...Tempo pienoTempo determinato
- ...documentation) Qualifications : For this multifaceted position we are looking for someone with: Industry training e.g. BTA CTA or MTA Bachelor studies (Biotech Biochemistry or Chemistry) or comparable Ideally professional experience within a R&D and GMP laboratory...TemporaneoTempo pienoRemote job