Regulatory Affairs - Global Labelling Manager job in Zürich, Switzerland

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Last Name*

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Job type: Permanent

Discipline: Project Manager

Location: Switzerland

This vacancy has now expired. Please see similar roles below...

Our client a global pharmaceutical company specializing in rare diseases, Nephrology and Cardiorenal therapeutic areas is looking to appoint a Regulatory Affairs Labelling manager in their Zurich offices. 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. Relocation support for candidates holding an EU or EFTA passport can be considered.

Responsibilities

Oversee arrangements and operation of external solution providers supporting GRAL activities.
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.
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.

If you are having difficulty in applying or if you have any questions, please contact Laura Storm at +44 208 138 0960.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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