Regulatory Affairs Clinical Solutions Specialist

Lieu: Switzerland - Glattbrugg/Zurich

Fonction: Regulatory Affairs

Niveau de Séniorité: Specialist

Medha Khanna

Senior Talent Acquisition Manager

Conditions pour les agences de placement

Votre profil

Vifor Pharma is currently undergoing unprecedented growth and portfolio expansion within rare diseases, Nephrology and Cardiorenal therapeutic areas. A permanent position in our Zurich offices in Global Regulatory Affairs Clinical Solutions has arisen as a specialist to support our growing pipeline and expansion of phase IV non interventional studies.

You will be an ambitious individual with some experience or knowledge of the clinical trials or drug development process and be interested in a career in regulatory affairs. On offer is a unique opportunity to be involved in key launch products and support studies in the real world.

Responsibilities

  • Support GRA CST members in the development and monitoring of long & short-term product regulatory planning related to the set-up, conduct, and completion of non-interventional clinical trials. 
  • Act as primary representative for GRA on assigned Clinical Study Teams (CST)
  • Support CST members with protocol development and risk analysis from a regulatory point of view
  • Support CST members in the auditing and records management for the regulatory sections of trial master files
  • Support posting of synopsis and study results on relevant international registers (EUDRACT, CT.gov, etc)
  • Monitor submission procedures (competent authorities) and archive submissions using the relevant GRA electronic systems
  • Support development of Vifor cross-functional R&D clinical procedures and PDs, and for organizational structure and systems related to non-interventional clinical research.
  • Monitor national and international relevant guidances and requirements through reviews of websites, publications, seminars, and similar sources, and communicate requirements to stakeholders

Minimum Requirements

  • University degree, preferably in pharmaceutical or health related field
  • 0-5 years’ experience in clinical development or regulatory affairs in the pharmaceutical industry (prescription drugs or generics)
  • Good computer skills, including proficiency with MS Office (including Word and PowerPoint)
  • Readiness of working in a fast-paced international team environment

Other Preferred Requirements

  • Proven, first-hand experience of working in a fast-paced team environment
  • Experience in working in a multinational regulatory affairs environment within the pharmaceutical industry
  • Familiarity with the global regulatory environment and GCP regulations
  • Familiarity with CTA/IND processes to support multinational clinical trials
  • Experience with eDMS, records management, or catalogue database systems

Languages:

Professional in English (oral and in writing)


A propos de nous

Le groupe Vifor Pharma est une entreprise pharmaceutique internationale spécialisée. Son ambition est de devenir le leader mondial dans les domaines de la carence en fer, de la néphrologie et des traitements cardio-rénaux. L’entreprise est le partenaire de choix pour les médicaments et les solutions innovantes axées sur le patient. Le groupe Vifor Pharma aspire à aider les patients du monde entier atteints de maladies graves et chroniques à mener une vie meilleure et plus saine. La société développe, fabrique et commercialise des produits pharmaceutiques offrant des soins de précision aux patients. Le groupe Vifor Pharma occupe une position de premier plan dans toutes ses activités clés. Il se compose des entreprises suivantes: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma (sa société commune avec Fresenius Medical Care); et OM Pharma.

Le groupe Vifor Pharma a son siège en Suisse et est coté à la Bourse suisse (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).

Pour de plus amples informations, veuillez consulter www.viforpharma.com/career

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Conditions pour les agences de placement