Regulatory Affairs (Consumer Healthcare) Industrial Placement 2022

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.

Take the first step in your career 

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.  

• Global Category Regulatory Affairs Associate (for new product introduction) (2 positions) 
• Product Lifecycle Management (PLM) Regulatory Affairs Associate (Non-Medicinals) (including licence renewals and variations) (1 position) 
• Product Lifecycle Management (PLM) Regulatory Affairs Associate (Medicinals) (including licence renewals and variations) (1 position) 
• Regulatory Affairs Associate – CMC (Chemistry, Manufacturing and Controls) which involves maintenance of Consumer Health dossiers post licence) (1 position)

Global Category Regulatory Affairs Associate 

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:  

• Providing regulatory advice to the business on aspects of cosmetic, medical device, medicine, food and supplements development. 
• Developing robust regulatory strategies, in order to secure competitive approvals and speed to market for our new products, working with the wider Regulatory teams. 
• Delivery of high quality regulatory files/dossiers, to agreed timelines. 
• Working with Commercial, Medical and Legal teams to develop and approve innovative and compelling product claims, ensuring the necessary substantiation is provided.  
• Ensuring the necessary product labelling, relating to product usage and safety, and mandatory labelling as per the applicable legislation. 
• Inputting to non-product related activities within the function, in order to direct new policy or pioneer new processes or improvements, to GSK CH’s competitive advantage. 
• Deliver Geographic Expansion of existing products to new markets/regions aligned with commercial plans of the business. This would involve working with all associated stakeholders, i.e. CMC, Clinical, Medical, Safety, Local Regulatory to provide the complete Regulatory dossier for submission and support for market specific requirements and legal type documents. 
• Working in conjunction with the wider Regulatory team to ensure support for the full life cycle of products, including: maintenance activities, design to value, complexity reduction, value engineering initiatives and change controls, with Supply Chain and Technical Excellence. 

Product Lifecycle Management (PLM) Regulatory Affairs Associate (Non-Medicinals and Medicinals) 

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: 
  • Renewals,  
  • Periodic Safety Assessment Reports,  
  • Administrative Variations  
  • Licence Cancellation Requests.  

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.   

Regulatory Affairs Associate – CMC (Chemistry, Manufacturing and Controls) 

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 categorizing 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 strategizes 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. 

Degree Requirements

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. 

Application Deadline

We recommend you apply as soon as possible, because we accept ongoing applications and will close this vacancy once we have enough applications. Start Date is July 2022.

Get to grips with our Recruitment Process 

If you have what we’re looking for apply today!  

This opportunity has the following recruitment stages you must successfully pass to be offered a placement year with GSK for 2022: 

• Eligibility Form  
• World of GSK Online Assessment  
• Application Form  
• Virtual Assessment Centre 

You’ll find hints, tips and guidance on our recruitment process on our website. We have changed the way we recruit in light of the COVID-19 pandemic, you can learn more about how our practices have adapted here. 

We’re 100% open to all talent – whatever your gender, marital status, religion, age, colour, race, sexual orientation, nationality or disability. We want to recruit the right people for GSK from the widest possible backgrounds, so we can better serve the diversity of our patients and consumers. And also because it’s the right thing to do. You can learn more about Inclusion and diversity at GSK  here. 

Need help with your application? 

Please email us at  UK.InternRecruitment@gsk.com and let us know how we can help you. Or email us your number and we’ll call you back. We’ll make all reasonable modifications to support you throughout the recruitment process and we’ll treat all information you give us in confidence. Please get in touch to help us process your application as soon as possible.  

As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, 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*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Please don’t hesitate to contact us if you’d like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on 0808 234 4391, or send an email ukdiversity.recruitment@gsk.com

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it.  Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

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.

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.