Oferta pracy

Senior Regulatory Specialist, Country Labelling

GSKAbout the company

  • Warszawa

    Warszawa, Masovian
  • Offer expired 7 days ago
  • Remote recruitment
  • contract of employment
  • full-time
  • specialist (Mid / Regular)

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.

  • Acting as the Subject Matter Expert in country/regional labelling content and process for markets with complex labelling requirements:

  • providing coaching, mentoring and knowledge sharing within GSK Labelling skill group

  • completing quality checks for colleagues’ outputs

  • effective management of interactions with Senior Stakeholders

  • taking accountability for the management of labelling deliverables for country/region, including delivery of high-quality outputs to timelines.

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 projects for different customers.

  • 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, development and established product lifecycle maintenance and regulatory processes.

  • Knowledge and understanding of product labelling (e.g. through direct exposure to the management of labelling documents/submissions/data; including label authoring).

  • Experience of maintenance of labelling documents in multiple countries/regions including knowledge of label document content, process and associated regulatory agency labelling requirements. Experience of more than 1 of the following regions/countries:

  • EU PI annexes (including EU CP/MRP/DCP procedures)

  • US PIs

  • Canadian Monographs

  • ROW PIs

  • Experience in authoring and/or updating Labelling SOPs, WIs, QRGs by identifying areas for efficiencies in existing Labelling processes

  • Proficient with computer software applications

  • Familiarity with medical terminology required

  • Ability to lead problem solving and negotiate solutions to complex labelling issues.

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.

  • Proven experience in defining strategy and ensuring delivery of Regional/Country labelling components throughout product lifecycle, product development and launch into markets.

  • Experience in supporting regional labelling leads in development/update of labelling content to be applied further to printed packaging components.

  • Experience in a variety of Regional Labeling activities with minimal input from function manager.

  • Detailed understanding of EU, US and rest of world label content, regulations and requirements.

  • Subject matter expert in associated Labelling processes.

  • Experience of labelling for pharmaceutical and vaccine products.

What we offer

  • Remote work (during pandemic)

  • Performance with Choice - post-covid you will be required to come into the office 1 day/week (subject to discussion with your line manager)

  • Stable and interesting job in one of the leading global healthcare companies.

  • Access to newest technologies and solutions.

  • Possibilities of development within the role and company’s structure.

  • Benefits (e.g. private medical healthcare, life insurance, sports card, pension plan, flexible working hours, home office).

  • Corporate culture based on our values: patient focus, integrity, respect and transparency.

  • Benefits

  • retirement pension plan

  • leisure zone

  • extra social benefits

  • holiday funds

  • charity initiatives

  • one shorter working day

GSK

GlaxoSmithKline 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 healthcare system participants, focusing on dialogue and transparent cooperation.

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. The Regulatory 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. Our Labelling team in Poland was set up as a part of the Central Regulatory Labelling team in August 2017 in Poznan. Since then the team has been constantly growing with regards to number of team members, locations (Poznan, Warsaw) and complexity of activities and processes supported. As the team is still expanding we are looking 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.

You will be responsible 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 .

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