Global Regulatory Affairs Labelling Manager - Zurich

Lieu: Switzerland - Glattbrugg/Zurich

Fonction: Regulatory Affairs

Niveau de Séniorité: Manager

Medha Khanna

Senior Talent Acquisition Manager

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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 Glattbrugg offices in Global Regulatory Affairs Labelling has arisen. This is an excellent opportunity to gain global experience within RA labelling in a high performing team at a time when multiple new drug development programs are ongoing. 

You will have significant experience within regulatory affairs in a pharmaceutical or biotechnology setting and exposure to labelling topics such as CCDS creation at the local or global level. This opportunity would suit someone seasoned in Regulatory Affairs from an SME looking to specialize in this area or an experienced Regulatory Labelling professional. 
Responsibilities 

Individual Assignment
  • Oversee arrangements and operation of external solution providers supporting GRAL activities

PRIMARY: Strategic Labelling
  • Support CCDS creation & update in collaboration with other line functions by providing 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
  • 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
  • Experience (5-8 years) working in regulatory affairs or supply chain specifically with labelling or packaging related responsibilities
  • Excellent command of English – both spoken and written. 
  • Expertise in the use of basic IT systems & tools.

Preferred Requirements
  • Higher university degree (Masters) in a relevant life sciences discipline, or specialised degree (Pharmacist).
  • Basic knowledge of drug development & labelling related issues
  • Experience in pharmaceutical packaging implementation
  • Familiarity with either pharmacovigilance concepts and practices, or with pharmaceutical supply chain processes
  • Fluency in German or French

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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