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Regulatory Specialist, Labelling Coordinator

  • Poznań, wielkopolskie pokaż mapę
  • Specjalista
  • 03.07.2018

    Pracodawca ma prawo zakończyć rekrutację we wcześniejszym terminie.

    Millions of people rely on your medicines. We rely on your skills to help to make them more accessible for everyone.

    To challenge, To change,
    more you will find on
    gsk.com/pl/kariera
    GSK is one of the leading global healthcare companies, driven by innovation and scientific developments. Our mission is to improve the quality of life, enabling people to do more, feel better and live longer. We conduct research aimed at improving the quality of life in three basic areas: Pharmaceuticals, Vaccines and Consumer Healthcare. In our activities, we strive to be a responsible partner, building trust-based relations with Polish healthcare system participants, focusing on dialogue and transparent cooperation. We provide Polish patients with over 300 medicines and healthcare products.
    Regulatory Specialist, Labelling Coordinator
    Workplace: Poznań
    WD174040

    Your Responsibilities:

    GSK is one of the leading global healthcare companies, driven by innovation and scientific developments. Our mission is to improve the quality of life, enabling people to do more, feel better and live longer. We conduct research aimed at improving the quality of life in three basic areas: Pharmaceuticals, Vaccines and Consumer Healthcare. In our activities, we strive to be a responsible partner, building trust-based relations with Polish healthcare system participants, focusing on dialogue and transparent cooperation. We provide Polish patients with over 300 medicines and healthcare products.

    Regulatory Specialist - Labelling Coordinator

    GSK is deeply committed to professional and personal development offering employment opportunities across a diverse collection of businesses and geographies. So you’ll flourish in an inspiring environment where personal growth plays a vital part in the changing face of the business. Most of all, you’ll enjoy the sense of purpose that comes from leading change in an industry that touches millions every day.

    Global Regulatory Platform and Delivery (GRPD) in GlaxoSmithKline is a regulatory affairs function which brings together the operation and execution aspects for key regulatory deliverables such as new chemical entity and product expansion dossiers, labeling outputs, license maintenance and lifecycle management dossiers and regulatory information management. GRPD provides regulatory support across the product lifecycle for pharmaceutical products (clinical development to market maturity).

    In this role you have an opportunity to work closely with GRA Labelling group who manages GRA Labelling data and documentation in regulatory systems in line with GRA standards and processes. In this role you have an opportunity to work closely with GRA Labelling group who manages GRA Labelling data and documentation in regulatory systems in line with GRA standards and processes. 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 Regulatory 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 Product Information (Labelling), which contains information for prescribers and patients.

    You will liaise with GSK colleagues to ensure that the Prescribing Information, Patient Leaflets and Packaging Components accurately state the Company's medical and scientific position regarding the safe and effective use of a GSK product.'

    If you are self-motivated, enjoy a challenge and seek satisfaction knowing your efforts are making a difference in someone’s life, then this opportunity is for you.

    Key responsibilities:

    • Manage documentation in support of global and country/regional product information (PI)
    • Coordinate documentation to support submission of country PI to Regulatory Agencies
    • Coordinate translations during the linguistic review process including interaction with GSK Local Operating Companies and submission to European Medicine Agency
    • Provide support to Global Regulatory Affairs (GRA) Labelling group to ensure quality and consistency of labeling documentation content and storage
    • Support GRA-Labelling processes and systems in accordance with GSK policies and procedures
    • Interface with other GRA or GSK operations functions to ensure consistency of processes and practices
    • Support other labeling functions as needed (such as Pack artwork activities, Global Labelling Committee work, audits)
    • Communicate regularly with Regulatory Manager/Team Lead to help in identification of any issues with business impact
    • Build and maintain quality relations with your internal and external stakeholders

    Basic qualifications:

    • Min. 2 years relevant experience (in pharmaceutical industry, regulatory or medical affairs)
    • Bachelor’s degree in chemistry, life sciences, pharmacy or other related science or technical field
    • Fluent Polish and English (both verbal and written)
    • Understanding of the pharmaceutical industry and regulatory processes
    • Understanding of product information/labeling
    • Familiarity with entry, tracking and registration data management systems
    • Ability to handle multiple tasks and to prioritize and schedule work to meet business needs
    • Flexible and analytical thinking
    • Detail-oriented, with emphasis on accuracy and completeness
    • Excellent interpersonal skills; ability to communicate, work in a diverse team environment and build relationships across a large organization
    Why GSK?:
    • Established job in one of the leading global healthcare companies.
    • Access to newest technologies and solutions.
    • Possibilities of development witihin the role and company’s structure.
    • Non-wage benefits (private medical healthcare, life insurance, sports card).
    • Free parking area and company canteen.
    • Work culture based on respect, honesty, transparency and focus on patient/consumer’s needs.




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