Global Regulatory Affairs Labelling Manager

vor 7 Monaten

Zurich, Schweiz CSL Behring Vollzeit

CSL Vifor is currently undergoing unprecedented growth and portfolio expansion within rare diseases, Nephrology and Cardiorenal therapeutic areas. A permanent global position in the Global Regulatory Affairs Labelling team has arisen. Which can be based at any of our CSL R&D Hubs (Maidenhead UK, Amsterdam, NL, Bern, CH, Zurich, CH, KOP, PA or Waltham, MA)

As part of our integration with CSL this role will be truly global and cross modality including speciality care, vaccines, plasma products, gene therapies and recombinant proteins, this role would span all products and therapeutic areas (Vaccines, Immunology, Haematology, Respiratory and Transplant, Cardiorenal, Nephrology) across the group of companies.

This is an excellent opportunity to gain global experience within Global labelling in a high performing team at a time when multiple new drug development programs are ongoing.

You will make significant contributions within regulatory affairs in a pharmaceutical or biotechnology setting and lead labelling activities such as CCDS creation/update and regional/local label development for major markets. This opportunity would suit someone who is currently working in regulatory labelling and is committed to this discipline.

**Responsibilities**:
PRIMARY: Strategic Labelling
- Develop and provide labelling strategies impacting the CCDS (company position) and product positioning in major markets
- Lead/manage CCDS creation and maintenance in collaboration with other line functions such as clinical development, safety, clinical pharmacology, medical affairs and commercial
- Leading GRA Labelling quality initiatives
- Plan CCDS roll-outs and strategic implementation into regional/local labels e.g., US PI, SmPC, PILs
- Support CCDS implementation into local labelling based on local regulation
- Facilitate and manage deviations of regional/local labels from the CCDS
- Fulfil Global Labelling strategist role and contribute to team activities as per mandated processes
- Collaborate with regional regulatory in responding to Health Authority questions on product information/labelling-related questions
- Interface with key stakeholders across the company e.g., Global Regulatory Leads, Regional Regulatory Leads, Safety, Clinical Development, Medical Affairs, Commercial, Legal etc.

SECONDARY: Operational Labelling & Packaging (all regions)
- Maintenance of specific product labelling related information in department databases, systems and external processes (e.g. PSMF, GLS, eDMS) and relevant tracking and planning systems (Trackwise)
- Validation/record of product information documents, e.g. SmPC, PIL, packaging
- Collaborate and support global labelling operations with artwork development and downstream implementation activities

Minimum Requirements
- University degree in Life Sciences or Pharmaceutical related fields
- Experience (5-8 years) working in regulatory affairs, safety or supply chain specifically with labelling
- 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
- Familiarity with either pharmacovigilance concepts and practices, or with pharmaceutical supply chain processes
- Fluency in German or French

**About CSL Vifor**:
CSL Vifor aims to become the global leader in iron deficiency and nephrology.

The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.

**We want CSL to reflect the world around us**:
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

**Do work that matters at CSL Vifor**:

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