Regulatory Specialist, Country Labelling
GSK
Warsaw, Poland
3 d. temu

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.

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 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 .

In your new role as the Regulatory Specialist, Country Labelling you will be responsible for :

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.

Basic 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.

Additional requirements :

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.

We offer :

We offer the opportunity to gain experience in well-known company, to cooperate with international environment where you can have an access to cutting-edge technology and work in friendly atmosphere.

We provide an attractive remuneration package and benefits (e.g. private medical healthcare, life insurance, sports card, pension plan, flexible working hours, home office), as well as the prospects of a comprehensive professional development.

Access to newest technologies and solutions.

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

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

  • LI-GSK
  • If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

    GSK is an Equal Opportunity / Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity / expression, age, disability, genetic information, military service, covered / protected veteran status or any other federal, state or local protected class.

    Important notice to Employment businesses / Agencies

    GSK does not accept referrals from employment businesses and / or employment agencies in respect of the vacancies posted on this site.

    All employment businesses / agencies are required to contact GSK's commercial and general procurement / human resources department to obtain prior written authorization before referring any candidates to GSK.

    The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business / agency and GSK.

    In the absence of such written authorization being obtained any actions undertaken by the employment business / agency shall be deemed to have been performed without the consent or contractual agreement of GSK.

    GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses / agencies in respect of the vacancies posted on this site.

    Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment.

    This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements.

    For more information, please visit GSK’s Transparency Reporting site.

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