Your Responsibilities: This role gives YOU the opportunity to lead key activities to progress YOUR career, the main of these are
Provides support for GRA (Global Regulatory Affairs) Labelling staff, Regulatory Matrix Teams and Local Operating Companies to ensure the timely update, management and communication of quality regional/country Product Information (PI)/labelling and supporting documentation.
Ensures effective coordination, communication and maintenance of regional/country labelling documents and data in regulatory systems in accordance with defined standards and processes.
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 check 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 required to perform translation of labelling text into identified languages.
Subject Matter Expert in country/regional labelling content and process.
Why you? Basic Qualifications: We are looking for professionals with these characteristics to achieve our goals:
University Degree in a Science, Life Sciences, or Scientific discipline.
1 – 2+ years 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.
Labelling experience, management of labelling documents, submissions and/or data, updating and managing Regional/Country Labelling documents, regulations/requirements in one or more regions.
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.
Advanced English Level, excellent written and verbal, ability to present information to diverse teams in global locations.
Microsoft Office knowledge.
Preferred Qualifications: However, if you have the following, it would be a plus:
Veeva Vault experience.
Experience of communicating with regulatory agencies.
Advanced Excel level
US labelling and /or regulatory experience.
If you feel this is your next career move, please apply up to December 11, 2023.
Why GSK? 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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
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.
Why Us? 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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. 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. Our inclusive workplace makes our employees feel engaged by the contribution they make, by affording them equal treatment regardless of actual or perceived characteristics. As so, when you apply for a job at GSK, it is not necessary to include on your resume information such as: race, color, ethnicity, age, gender, sexual orientation, marital status, religion, origin, photographs or any other personal characteristics. Find out what life at GSK is really like www.gsk.com.
