Oferta pracy

Regulatory Specialist, Country Labelling

GSK

  • Warszawa

    Warszawa, Masovian
  • offer expired a month ago
  • contract of employment
  • full-time
  • specialist (Mid / Regular)
  • remote recruitment

Your responsibilities

  • Authoring and compiling Regional/Country PI as per regulatory authority labelling requirements and GSK process and standards.

  • Authoring and compiling market-specific supporting documentation for labelling submissions in accordance with regulatory authority requirements and GSK process and standards.

  • Providing support to global and local GRA team members through preparation of other labelling documents as required

  • Complete quality and consistency checks of labelling document content.

  • Effective coordination and management of labelling documentation and data in regulatory systems.

  • Providing advice regarding regulatory authority labelling requirements and GSK labelling process and standards to GRA global/local roles and via Regulatory Matrix Teams.

  • Effective communication with GSK staff (including GRA, Global safety and medical, and Local Operating Companies) to author, compile and deliver quality labelling documents.

  • Supporting other regulatory functions and participating in other projects and activities as needed, such as leading the design and implementation of changes to labelling processes and evaluation of new agency labelling requirements.

Our requirements

  • Relevant experience (in pharmaceutical industry, life sciences research or regulatory).

  • Successfully performed within a regulated or quality-critical environment such as pharmaceutical industry research, pharmacy, safety or regulatory.

  • Attention to detail, significant experience of document and database management, excellent organization and time management skills to handle multiple tasks.

  • Excellent written and verbal English language communication skills and ability to present information to diverse colleagues in global locations in a clear and concise manner.

  • Ability to think flexibly in order to meet constantly shifting priorities and timelines.

  • Broad understanding of the pharmaceutical industry, drug development environment, and regulatory processes.

  • An understanding of labelling (e.g. through direct or indirect exposure to the management of labelling documents/submissions/data).

  • Experience in updating and managing Regional/Country Labeling documents.

  • Proficient with computer software applications

  • Familiar with medical terminology

  • Ability to negotiate solutions to moderate labeling issues and proactively identify improvements for labelling processes

  • Knowledge of labelling regulations/requirements in 1 or more regions.

Optional

  • Regulatory document management experience (particularly experience of working with and amending Product Information/Labelling Documents).

  • Experience and familiarity of working within regulatory systems and communication tools.

  • Some experience of managing local and global labelling documents and submissions.

  • Experience of communicating with regulatory agencies.

  • Experience of EU (including Linguistic review) and US label content and requirements.

  • Experience of XML Labelling.

  • Benefits

  • retirement pension plan

  • leisure zone

  • extra social benefits

  • holiday funds

  • charity initiatives

  • one shorter working day

  • life Insurance

  • sport and recreation cards

  • annual bonus

  • canteen for employees at site (with discounts)

  • flexible working options available for most positions

GSK

GSK is in the midst of an exciting period of investment and growth in its new European financial centre, located in Poznan and Warsaw, with almost 300 new employees joining to date.

The European financial centre is responsible for providing a wide range of business services to the European region, as part of a wider network of regional hubs around the globe. These centres of expertise work together as a One Finance team to support GSK’s global operating model by delivering best in class services, sharing best practice and knowledge and working closely with other markets and colleagues, supported by our global headquarters in London.

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The role

At GSK, we’re constantly developing new products and improving our established medicines to improve the quality of human life by enabling people to do more, feel better and live longer. Ensuring these products are correctly prescribed and used is essential, and that’s where our labelling team is key. The Labelling team supports our portfolio of medicines by ensuring that the information relating to the safety and efficacy of our products reaches patients and prescribers. This is done through the creation and management of our Company Core Datasheet, which contains information for prescribers and patients.

GSK currently has opportunities in its Global Regulatory Affairs (GRA) - Labelling department, within research and development. These roles are perfectly suited for enthusiastic regulatory professionals with experience or an interest in developing patient and prescriber information and who would like to pursue a career in a global pharmaceutical company. Our Labelling team supports a product during development and throughout its lifecycle, and we are the coordinating authors of Company Core Datasheets, country and regional prescribing/patient information for GSK pharmaceutical products

The Regulatory Specialist, Country Labelling is responsible for effective coordination, communication and maintenance of regional/country labelling documents (for multiple markets/regions) and data in regulatory systems in accordance with defined standards and processes. You will provide support to GRA Labelling colleagues, Regulatory Matrix Teams and Local operating companies to ensure timely update, management and communication of quality regional and local labelling/Product Information (PI) and supporting documentation required for local submissions.