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Regulatory affairs specialist Jobs in Baar

Zuletzt aktualisiert: vor 1 Tag
Clinical Development Lead / IVD and Liver Cancer

Clinical Development Lead / IVD and Liver Cancer

Coopers iET AGZug, Canton of Zug, Switzerland
Homeoffice
Quick Apply
Clinical Development Lead / IVD and Liver Cancer ROCGJP00029130.The Clinical Development Lead Oncology is responsible for planning and implementation of Clinical Development activities for novel medi...Mehr anzeigenZuletzt aktualisiert: vor 1 Tag
Manager Medical Affairs (m / f / w) Diabetes Care Austria and Switzerland

Manager Medical Affairs (m / f / w) Diabetes Care Austria and Switzerland

AbbottBaar, Zug, Switzerland
Abbott Diabetes Care is a global leader in diabetes management, committed to helping people with diabetes lead healthier, happier lives. Through continuous innovation and a steadfast commitment to q...Mehr anzeigenZuletzt aktualisiert: vor 22 Tagen
Clinical Development Lead Oncology

Clinical Development Lead Oncology

EurojobRotkreuz
For our international medical partner, Roche Diagnostics Int Ltd.Rotkreuz, we are looking for a qualified and motivated.Clinical Development Lead Oncology. The Clinical Development Lead Oncology is ...Mehr anzeigenZuletzt aktualisiert: vor 2 Tagen
  • Gesponsert
Quality Assurance Expert Pharma

Quality Assurance Expert Pharma

Kolb Distribution AGHedingen, CH
Leitung von Projekten für die Weiterentwicklung des Standorts im Bereich pharmazeutische Hilfsstoffe.Erstellen und Pflegen von regulatorischen und Qualitätsdossiers für unsere Produkte (z.Erstellen...Mehr anzeigenZuletzt aktualisiert: vor 14 Tagen
Director, Europe & Canada (EUCAN) Communications

Director, Europe & Canada (EUCAN) Communications

AstraZenecaBaar,Switzerland
Vollzeit
Director, Europe & Canada (EUCAN) Communications.Competitive salary and benefits.Here at AstraZeneca, you’ll be valued for your unique knowledge. It means we are trusted with personal accountability...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
  • Gesponsert
AI Specialist in healthcare supply domain

AI Specialist in healthcare supply domain

Entrydell SAZug, CH
We are seeking a Junior AI Specialist to join our team at a leading European provider of medical equipment.In this role, you will collaborate across departments to integrate AI technologies like.LL...Mehr anzeigenZuletzt aktualisiert: vor 23 Tagen
  • Gesponsert
Clinical Development Lead Oncology

Clinical Development Lead Oncology

ITech Consult AGZug, CH
Clinical Development Lead Oncology (m / f / d) - IVD / liver Indication / Medical Device / ICH-GCP, IVDD / IVDR, MDR, FDA, NMPA / VACC / English. For our customer Roche Diagnostics International AG based ...Mehr anzeigenZuletzt aktualisiert: vor 1 Tag
INTERNATIONAL REGULATORY AFFAIRS 60%

INTERNATIONAL REGULATORY AFFAIRS 60%

gloor & lang Pharma and Biotech RecruitingRegion Zürich-Zug
Innovative Biologic submissions – early to late phase.Our client is an R&D driven biotech company based in in Zurich.Own Research and development activities as well as international clinical develo...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Director of Regulatory Affairs – Switzerland (m / f / d)

Director of Regulatory Affairs – Switzerland (m / f / d)

ViatrisZug, Zug, Switzerland
Vollzeit
At VIATRIS, we see healthcare not as it is but as it should be.We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers p...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Associate Regulatory Affairs Director – Join Innovative TeamNonStop Consulting

Associate Regulatory Affairs Director – Join Innovative TeamNonStop Consulting

NonStop ConsultingZug, Switzerland
Homeoffice
Join a Leading Regulatory Affairs Team!.With a diverse portfolio of iconic brands across 20 countries, our client operates in Australia & New Zealand, Asia, and Africa. Their team is dedicated to pu...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Senior Manager, Regulatory Affairs CMC

Senior Manager, Regulatory Affairs CMC

Gilead Sciences Switzerland SarlZug, Switzerland
Vollzeit
The CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs International Affiliate Team is seeking a motivated, curious, flexible, and culturally aware experienced Regulatory professional ...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Legal Counsel - Regulatory

Legal Counsel - Regulatory

Copper.coZug, Switzerland
Copper is a digital asset technology company dedicated to helping institutional investors safely acquire, trade, and store crypto assets. Built and led by Dmitry Tokarev, a software and financial en...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Test Engineer

Test Engineer

FLEXSISRisch-Rotkreuz, Zug, CH
Teilzeit
As a preferred supplier for Roche Diagnostics in Rotkreuz, we are looking for a motivated.This is a full-time position (100%) with a one-year duration and the possibility of extension.The earliest ...Mehr anzeigenZuletzt aktualisiert: vor 11 Tagen
QC Specialist

QC Specialist

Gi Group SARotkreuz, Zug, Schweiz
Quick Apply
Der Weltmarktführer im Bereich In-vitro-Diagnostik, Roche Diagnostics in Rotkreuz (ZG), sucht eine kommunikative und teamfähige Persönlichkeit mit einer abgeschlossenen Berufsausbildung im (chemisc...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Regulatory Affairs Manager (m / w / d)

Regulatory Affairs Manager (m / w / d)

Real StaffingZug, Switzerland
Responsible for leading regulatory affairs activities for assigned projects and programs and for leading affiliate RA to identify and complete national regulatory requirements for assigned projects...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Regulatory Affairs Manager for Austria and Switzerland (Alpine region)

Regulatory Affairs Manager for Austria and Switzerland (Alpine region)

Alexion PharmaceuticalsSwitzerland,Baar
Regulatory Affairs Manager for Austria and Switzerland (Alpine region).Reports to : Associate Director, CENE Regulatory Affairs. The Regulatory Affairs Manager works under the responsibility of the A...Mehr anzeigenZuletzt aktualisiert: vor 3 Tagen
Regulatory Professional - Zug, Switzerland or London

Regulatory Professional - Zug, Switzerland or London

Partners GroupZug, CH
The Regulatory Professional is responsible for managing trading documentation, correspondence, and regulatory information in support of the Treasury Trading team in the global Public Markets busine...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Corporate Affairs Manager (all genders) Switzerland & Austria

Corporate Affairs Manager (all genders) Switzerland & Austria

MarsBaar, Switzerland
Vollzeit
Corporate Affairs Manager (all genders).Vollzeit mit Homeoffice-Option bis 50%.Arbeitsort : Baar (Schweiz) ODER Wien (Österreich). Als Corporate Affairs Manager (all genders) Switzerland & Austria is...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Director, Global Regulatory Affairs, Precision Medicine & Digital Health

Director, Global Regulatory Affairs, Precision Medicine & Digital Health

1925 GlaxoSmithKline LLCZug, Switzerland
Vollzeit
Ensure the development of appropriate Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital health asset(s) supporting across ...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Operations Quality Engineer

Operations Quality Engineer

TecanMännedorf, CH
Ever wondered how your skills and unique background could impact the world of tomorrow?Join our Quality Operations team and bring your passion and talent to work. Join our Quality Operations team at...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Clinical Development Lead / IVD and Liver Cancer

Clinical Development Lead / IVD and Liver Cancer

Coopers iET AGZug, Canton of Zug, Switzerland
Vor einem Tag
Anstellungsart
  • Homeoffice
  • Quick Apply
Stellenbeschreibung

Clinical Development Lead / IVD and Liver Cancer ROCGJP00029130

The Clinical Development Lead Oncology is responsible for planning and implementation of Clinical Development activities for novel medical value diagnostic solutions in the areas of  Chronic Liver Diseases , with a primary focus on  Liver fibrosis.

Duration : 12 months / possible extension

Location : Rotkreuz

Full time, Hybrid

Responsibilities :

  • Serve as a subject matter expert for Liver Oncology, clinical study design and evidence generation strategies for internal and external stakeholders in the assigned indication area.
  • Responsible for critical review of study results, protocol and report generation to support new product development.
  • Works with colleagues from Business, Medical Affairs, Clinical Operations, Regulatory Affairs, Biometrics, Development, Quality, and other functions to ensure appropriate implementation of clinical development strategies.
  • Builds and maintains strong, collaborative relationships with cross-functional leaders, key internal and external stakeholders and other alliance partners, in meeting business goals and ensuring operational excellence.
  • Act as an ambassador and representative of Clinical Development establishing effective collaborative relationships with key functions for new and existing products, incl. clinical utility, intended use and claim extensions.
  • Play a leadership role in maintaining clinical, regulatory, and scientific expertise as it relates to IVD product development and regulatory documentation. Leads medical / scientific input and preparation of regulatory submissions as well as responses to reviewers from regulatory agencies.
  • Drives competitive differentiation, innovation and early pipeline activities and develops intellectual property strategy.
  • Responsible for comprehensive literature reviews, supervises collation of relevant clinical and scientific information from different sources, and creates new scientific content (without guidance / direction).
  • Demonstrate leadership skills; ability to mentor and provide an environment for personal and professional growth.

Must Haves :

  • Medical degree or advanced degree in Life Sciences (PhD, PharmD or equivalent degree) with relevant expertise in the Healthcare Industry and / or academic institutions
  • Min. 2-3 years of industry experience after PhD or coming straight from the industry with at least  5+ years of experience in IVD
  • Strong experience in liver Indication (Fibrosis and / or Liver cancer)
  • Min. 5+ years academic, diagnostics or pharma industry experience, preferably, having experience in IVD or Medical Device development in all stages of global studies, development of study protocol design, report writing and leading matrixed teams
  • Ability to lead clinical development studies / programs and good knowledge in applicable standards and regulations (ICH-GCP, IVDD / IVDR, MDR, FDA, NMPA regulations etc.) especially in global studies in the US and negotiation with the FDA
  • Coopers iET AG ist eine agile Schweizer Recruiting Agentur , die Spezialisten und Führungskräfte in den Bereichen IT, Life Sciences, Engineering und Finance vermittelt. Mit flexiblen Ansätzen bringen wir Kandidat : innen und Unternehmen zusammen, die nicht nur fachlich, sondern auch menschlich zusammenpassen.