Senior Regulatory Specialist, Global Labelling
GSK
Warsaw, Poland
1 d. temu

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 Senior Regulatory Specialist, Global Labelling is responsible for effective coordination, communication and maintenance of global 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 global labelling / Product Information (PI) and supporting documentation required for local submissions .

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

Authoring and compiling 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.

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 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.

    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.

    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.

    We offer :

    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.

    In response to this job offer, please submit your CV in English.

  • 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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