Senior Regulatory Specialist, Country Labelling

Job title:

Senior Regulatory Specialist, Country Labelling

Company:

GlaxoSmithKline

Job description

The Senior 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 ompanies 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 Senior Regulatory Specialist, Country Labelling you will be responsible for:Author and compile Regional/Country PI as per regulatory authority labelling requirements and GSK process and standards.Author and compile market-specific supporting documentation for labelling submissions in accordance with regulatory authority requirements and GSK process and standards.Provide 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.Efficiently coordinate and manage labelling documentation and data in regulatory systems.Provide advice regarding regulatory authority labelling requirements and GSK labelling process and standards to GRA global/local roles and via Regulatory Matrix Teams.Effectively communicate with GSK staff (including GRA, Global safety and medical, and Local Operating Companies) to author, compile and deliver quality labelling documents. May communicate with Regulatory Agencies and third parties on behalf of GRA labelling staff.Support other regulatory functions and participate 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.For some roles, may be required to perform translation of labelling text into identified languages.Subject Matter Expert in country/regional labelling content and process for markets with complex labelling requirements:provides coaching, mentoring and knowledge sharing within GSK Labelling skill groupcompletes quality checks for colleagues’ outputseffectively manages interactions with Senior Stakeholderstakes accountability for the management of labelling deliverables for country/region, including delivery of high-quality outputs to timelinesRequirements:Relevant experience (in pharmaceutical industry, life sciences research or regulatory)Masters degree Area of Specialisation: Science or Life Sciences ( must have)Successfully performed within a regulated or quality-critical environment (such as pharmaceutical industry research, pharmacy, safety or regulatory)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.Knowledge of labelling regulations/requirements in 1 or more regions ( EU preffered)Attention to detail, significant experience of document and database management, excellent organization and time management skills to handle multiple tasksExcellent written and verbal English language communication skills and ability to present information to diverse colleagues in global locations in a clear and concise mannerAbility to think flexibly in order to meet constantly shifting priorities and timelinesUnderstanding of the pharmaceutical industry, drug development environment, and regulatory processesAbility to negotiate solutions to moderate labeling issues and proactively identify improvements for labelling processes.What we offer:Career at one of the leading global healthcare companiesHybrid type of work – 2/3 days per week from the officeContract of employmentAttractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)Life insurance and pension planPrivate medical package with additional preventive healthcare services for employees and their eligible counterpartsSports card (Multisport)Possibilities of development within the role and company’s structurePersonalized learning approach (mentoring, online training’ platforms: Pluralsight, Business Skills, Harvard Manage Mentor, Skillsoft and external training)Extensive support of work life balance (flexible working solutions, health & well-being activities)Supportive community and integration eventsModern office with creative rooms, fresh fruits everydayFree car and bike parking, locker rooms and showers#LI-GSK#LI-HYBRIDWhy GSK?Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.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/ AgenciesGSK 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.

Expected salary

Location

Warszawa, mazowieckie

Job date

Thu, 23 May 2024 23:36:23 GMT

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