Global Regulatory Affairs Labelling Specialist - Zurich or St Gallen Location

Ort: Switzerland - Glattbrugg/Zurich

Senioritätslevel: Specialist

Ihr Profil

CSL Vifor a CSL company is currently undergoing unprecedented growth and portfolio expansion within rare diseases, Nephrology and Cardiorenal therapeutic areas. A permanent position in our Zurich or St Gallen offices, Switzerland in Global Regulatory Affairs Labelling has arisen. This is an excellent opportunity to further your 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 labelling aspects of the discipline. This opportunity would suit someone either with a good grounding in regulatory affairs or drug development looking to gain global experience or an experienced labelling person seeking a new challenge.

Key Measures of Success 

  • Works effectively with a wide variety of personnel across diverse teams and functions within the corporation and at external partner companies
  • Resolves issues appropriately, and in a customer-oriented manner
  • Communicates clearly and accurately, both orally and in writing
  • Creative, solution-oriented work approach; takes a proactive approach to identifying service support, information flows and processes
  • Meets timelines, or proactively identifies potential delays and acts to minimise them
  • Delivers high-quality, accurate documents and work products according to agreed upon processes

Individual Assignment
  • Represent Global Regulatory Labelling group in relevant governance forums
  • Oversee arrangements and operation of external solution providers supporting Global Labeling and Data Strategies activities

PRIMARY: Strategic Labelling
  • Leading GRA Labelling quality initiatives 
  • Support for CCDS implementation into labelling including planning for roll-outs and strategical implementation into the local SmPC, PIL and labelling based on local regulation and management of deviations
  • CCDS development meeting activities as required: fulfil GRAL role and contribute to team activities as per mandated processes in collaboration with relevant governance bodies
  • 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 information in department databases, systems and external processes (e.g. PSMF, XEVMPD, GLS, eDMS) and relevant tracking and planning systems
  • Validation/record of product information documents e.g. SmPC, PIL, packaging 
  • Budget & vendor management for labelling activities (e.g. readability testing, translations)

Data Strategies
  • Lead baseline data strategy for products assigned
  • Collaborate with clinical solutions partner and other regulatory functions to provide data strategies deliverables
  • Respond and develop responses upon requests e.g. from regions, market access
  • Participate in the capability development for Data Strategies

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) or laboratory
  • 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

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