Regulatory Specialist, Country Labelling
Regulatory Specialist, Country Labelling
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Are you ready to take your regulatory expertise to the next level Join GSK as aRegulatory Specialist Country Labellingand play a pivotal role in ensuring the timely update management and communication of high-quality regional/country Product Information (PI) and labelling documentation. This opportunity allows you to leverage your skills in coordination communication and regulatory systems management to make a real impact in the pharmaceutical industry.
Key Responsibilities:
As a Regulatory Specialist you will:
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 .
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 contributing to the implementation of changes to labelling processes and evaluation of new agency labelling requirements.
For some roles may be to perform translation of labelling text into identified languages.
May become a SME in country/regional labelling content and process.
Why You
Basic Qualifications:
Masters Degree within life science
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.
Experience preferred
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.
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.
Why GSK
What we offer:
Career at one of the leading global healthcare companies
Contract of employment
Hybrid type of work ( 2/3 days per week from the office)
Attractive reward package (annual bonus & awards for outstanding performance recognition awards for additional achievements and engagement holiday benefit)
Life insurance and pension plan
Private medical package with additional preventive healthcare services for employees and their eligible counterparts
Sports cards (Multisport)
Possibilities of development within the role and companys structure
Personalized learning approach (mentoring online training platforms: Keep Growing Campus LinkedIn Learning 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 events
Modern office with creative rooms fresh fruits every day
#LI-GSK
#LI-Hybrid
As an Inclusive employer we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at to discuss your needs.
Why 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 its 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.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race color religion sex (including pregnancy gender identity and sexual orientation) parental status national origin age disability genetic information (including family medical history) military service or any basis prohibited under federal state or local law.
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 GSKs 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 GSKs compliance to all federal and state US Transparency requirements. For more information please visit the Centers for Medicare and Medicaid Services (CMS) website at Experience:
Unclear Seniority
Employment Type
Full-Time
Key Skills
Similar Jobs
Dr. Job is an online platform that connects employers with skilled job seekers, facilitating the search for job opportunities and top talent. Established in 2015. Dr. Job Pro has emerged as the world premier job portal, attracting thousands of job seekers every day from all over the world.
Follow Dr.Job
Dr Job FZ LLC. 2025 © All Rights Reserved