Global Regulatory Specialist (Labelling) - 6 months fixed term contract

Lieu: Switzerland - Glattbrugg/Zurich

Fonction: Regulatory Affairs

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 6 months Fixed Term contract in the Global Regulatory Affairs Labelling has arisen. This is an excellent opportunity to gain global regulatory affairs experience in a truly innovative environment. 

You will have some experience within pharmaceutical or biotech regulatory affairs at the global or local level and ideally some exposure to labeling aspects of the discipline.. This opportunity would suit someone either with a good grounding in regulatory affairs looking to gain global experience or an experienced labeler seeking a new challenge for a fixed period. 

PRIMARY: Strategic Labelling
  • Leading CCDS creation & update in collaboration with other line functions; strategic input related to CCDS impact on labelling
  • Leading GRA Labelling quality initiatives 
  • Support for CCDS implementation into local labelling including planning of roll-outs and strategical implementation into the local SmPC, PIL and labelling based on local regulation and management of deviations
  • CMRST meeting activities: fulfil GRAL role and contribute to team activities as per mandated processes
  • Support for responding to Health Authority questions on product information-related issues
  • Interface with key stakeholders across the company

SECONDARY: Operational Labelling & Packaging (all regions)
  • Support and recommendations to GRA department and other departments on labelling related issues
  • Maintenance of specific product labelling related information in department databases, systems and external processes (e.g. PSMF, XEVMPD, GLS, eDMS) and relevant tracking and planning systems (Trackwise)
  • Validation/record of product information documents, e.g. SmPC, PIL, packaging 
Minimum Requirements
  • University degree in Life Sciences or Pharmaceutical related fields
  • Some experience (1-3 years) working in the pharmaceutical industry, preferably in regulatory affairs or related field (e.g. clinical, medical, quality, supply chain).
  • Excellent command of English – both spoken and written. 
  • Expertise in the use of basic IT systems & tools.

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

Afficher/masquer le contenu

Postuler
Partager
Xing Send to a friend

Conditions pour les agences de placement