In GSK Consumer Healthcare, we are on an incredible journey as we prepare to create a new, standalone, world leading company with a 100% single-minded focus on everyday health. We are doing this at a time when the work we do has never mattered more. With the COVID pandemic, people are increasingly looking for ways to manage their own health and wellbeing and to take care of their families. This is where we come in. With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we are uniquely placed to deliver better everyday health to millions of people around the world and grow a strong, successful business. This is an opportunity to be part of something special.
Are you interested in ensuring that products such as cosmetics, pharmaceutical medicines, and medical devices meet legislative requirements by controlling the safety and efficacy of products? Then Regulatory affairs is the role for you!
Regulatory Affairs involves devising strategies with the most appropriate classification for a consumer health product to reach the market, as well as preparing dossiers for submission to regulatory agencies globally and then once launched, maintaining the dossiers post licence and filing applications to make changes to the licence where necessary.
These roles are an excellent opportunity to learn about the health and pharmaceutical industry and experience the role of Regulatory Affairs in shaping business strategy.
GSK Consumer Healthcare develops and markets a range of consumer healthcare products, across the categories of Oral & Skin Health, Pain Relief, Respiratory, Nutrition/Gastrointestinal Health and Wellness. The purpose of this role, within the Oral Health Category, is to provide regulatory support to assigned products/projects, to enable our products to be successfully introduced or maintained globally. In this role, the individual will support other members of the Regulatory team, but may also work in project teams, involving other teams within the business, such as Medical, Marketing, Supply Chain and Quality, and with regulatory colleagues across the world, to ensure all regulatory requirements are met for both new innovation and existing products.
In this role, you will support the Global Regulatory Affairs Oral Health Category team, covering a variety of well-known brands and product classifications. This team is responsible for:
The purpose of this role is to provide regulatory support to assigned products/projects or parts of projects to enable GSK CH’s products to be successfully maintained around the world.
In this role, the individual will be supporting the PLM Regulatory Affairs team by working cross-category - covering all brands, classifications and therapeutic areas.
The PLM team are responsible for the following activities.
Ensure maintenance activities of product licences are completed globally, including
This involves working with all associated stakeholders, i.e. CMC, Category, Clinical, Medical, Safety, Local Regulatory to provide the complete Regulatory dossier for submission.
Expertise to support Market Specific Requirements and legal type documents which are applicable for all types of submissions. E.g. Power of Attorneys, Certificate of Pharmaceutical Products, Certificate of Free Sale, other supporting Regulatory Statements and arrange legalisation with Foreign Office/Embassies as required.
This is done by delivering and managing the processes, systems, and communication with internal teams to enable right first time submissions for GSK’s consumer products around the world.
The purpose of this CMC (Chemistry, Manufacturing and Controls) role is to provide regulatory support to post licenced consumer Health products (Oral Health Category) by assessing any life-cycle changes (manufacturing process changes, shelf life changes, manufacturing site transfers, batch size increases, new flavours etc) to the CMC section of the dossier (cosmetic, medicinals or devices) to ascertain if there is any Regulatory impact to the dossier. The candidate will work alongside other departments to get a useful insight into what goes on within the pharmaceutical industry in order to provide consumers / patients with a safe, effective product.
The CMC section of a dossier contains the information on the formulation, manufacturing process, the analytical test methods and specifications of the ingredients and finished product, packaging, stability etc.
You will be required to take the necessary action to update the dossiers by liaising with all associated stakeholders, i.e., analytical, stability, manufacturing sites, microbiology, and Local Operating Companies around the globe etc. as well as update the Regulatory Systems. Updating the dossier involves the process of categorising the changes into various types of classes (as outlined in the guidelines issued by Health Authorities), and subsequently authoring the dossier sections, supported by sound and scientifically-robust justifications. Here, you will be able to see how the theoretical concepts that you have so-far learnt only in your textbooks correlate to practical real-life situations.
You will also gain an insight into how a Regulatory Affairs person strategises a dossier submission with data from associated stakeholders in the least-possible time, to obtain faster approval from the Health Authorities.
Also, you will be required to provide regulatory advice for any projects where changes to the product are being made.
In this role the individual will need to support members of the regulatory team and will also be required to work and build trusting relationships with multi-functional and project Teams, to ensure all regulatory requirements are met for both all existing Consumer Health products (within the Oral Health Category) according to GSK Values.
All-in-all, this job gives not only gives you an opportunity to hone your scientific skills but also helps develop the analytical, logical and strategic qualities.
You should be studying a Science degree. You will have completed a minimum of 2 years of your undergraduate degree, but will not have graduated at the start of your placement. You may be expected to provide evidence from your university to show you will be an undergraduate student for the duration of the placement year and they are supportive of your placement.
We recommend you apply as soon as possible, because we accept ongoing applications and will close this vacancy once we have enough applications.
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