Regulatory Affairs Labelling Manager

☞ Vifor Pharma

View: 165

Update day: 25-04-2024

Location: St. Gallen St. Gallen SG

Category: Pharmacist / Pharmaceutical representatives

Industry: Pharmaceutique et biotechnologie

Job type: CDI

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Job content

Vifor Pharma is currently undergoing unprecedented growth and portfolio expansion within rare diseases, Nephrology and Cardiorenal therapeutic areas. A permanent position in our St Gallen 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

About Us

The Vifor Pharma Group is a global specialty pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is the partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care); and OM Pharma.

Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).

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Deadline: 09-06-2024

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