Regulatory Specialist ,Labelling Coordination (Temp. contract -12 Months

Job Description

Are you looking for a regulatory affairs role that will enhance your documentation knowledge and allow you to help shape systems strategy?  If so, this Regulatory Specialist, Country Labelling role could be an exciting opportunity to explore. As a Regulatory Specialist, Country Labelling , you will be providing support to GRA Labelling staff to ensure the timely management and communication of global, country and regional Product Information/labelling documentation. Effective coordination, communication and maintenance of labelling documents and data in regulatory systems in accordance with defined standards and processes.  This role will provide YOU the opportunity to lead key activities to progress YOUR career.  These responsibilities include some of the following: Key Responsibilities:

• Support country/regional labelling for Pharma and Vaccines in compliance with GSK Labelling processes and external requirements. candidate will deliver the following aspects of labelling:
  • Author and compile Regional/Country PI [Product Info.] 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.
• Storage of labelling documentation in regulatory systems including communication of approved Global and regional/country PI
• Efficient communication with GSK staff (including Global Regulatory Affairs, Global safety and medical and Local Operating Companies) to collate, compile and perform quality checks of labelling documents
• Management of GRA Labelling data in relevant regulatory systems e.g. Veeva Vault
• Supporting GRA-labelling processes and systems in accordance with GSK policies and procedures
• Supporting other labelling functions and participation in other projects and activities as needed, such as contributing to the implementation of changes to processes within GRA Labelling.

Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s degree in Life Sciences [e.g. Pharmacy].
• 1-3 years relevant experience (in pharmaceutical industry, life sciences research or regulatory).
• Excellent English language skill is a must for this role
• Excellent command of French language skill (Written and understanding ) is a must for this role
• Successfully performed within a regulated or quality-critical environment such as pharmaceutical industry research or regulatory).
• Attention to detail, experience of document and database management, well-developed organization and time management skills.
• Excellent written and verbal communication skills and ability to present information in a clear and concise manner
• Ability to think flexibly in order to meet shifting priorities and timelines.

Post Closure Date: 26.Feb.2025 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, 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. Contact information: You may apply for this position online by selecting the Apply now button. 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.