Regulatory Affairs - R&D CH

GSK Undergraduate Industrial Placement Job Title: Regulatory Affairs Industrial Placement

Reference Number: 3021f

 

Salary: Competitive

 

Degree Requirements: Must be undergraduate studying a Life Science or Pharmaceutical related science degree (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering)

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 will be expected to provide evidence from your university to show you will be an undergraduate student for the duration of the placement year.

 

Duration: 1 year (approximately)

 

Locations: GSK House – Brentford, Weybridge

 

Scope of the roles:

Would you relish the opportunity to support our business to help improve the lives of people globally? Do you want to gain experience in a responsive, innovative, global business? A placement with GSK Consumer Healthcare (GSK CH) will give you the practical experience to complement your studies and we are committed to supporting your personal and professional growth.

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.


We have 4 distinct roles available within Regulatory Affairs:

 

1.       Oral Health Category (for new product introduction)

2.       Respiratory & Skin Health Category (for new product introduction)

3.       Product Lifecycle Management (Licence renewals and variations)

4.       CMC (Chemistry, Manufacturing and Controls - which involves maintenance of Consumer Health dossiers post licence)


 

There are 4 available positions at Weybridge and 1 further position based at Weybridge with occasional travel to the GSK Headquarters, Brentford, UK.

Role 1: Global Category Regulatory Affairs Associate – Oral Health

Role 2: Global Category Regulatory Affairs Associate – Respiratory & Skin Health

GSK CH develops and markets a range of consumer healthcare products, across the categories of Oral Health, Pain Relief, Respiratory & Skin Health, and Wellness. The purpose of these roles, one within Oral Health Category and one within Respiratory & Skin Health, 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 Category teams, covering a variety of well-known brands and product classifications. This teams are 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.

·         Delivering Geographic Expansion of existing products to new markets/regions aligned with commercial plans of the business. This involves 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.

Role 3: Product Lifecycle Management (PLM) Regulatory Affairs Associate

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.

 

1.    Ensure maintenance activities of product licences are completed globally, including

·         Renewals,

·         Periodic Safety Assessment Reports,

·         Administrative Variations

·         Licence Cancellation Requests.

 

2.    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, Category, Clinical, Medical, Safety, Local Regulatory to provide the complete Regulatory dossier for submission.

 

3.       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. 

Role 4: 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.

 

These roles are an excellent opportunity to learn about the consumer healthcare industry and experience the role of Regulatory Affairs in shaping business strategy.

 

Take a look at this short video to find out more about this placement


Close Date: Tuesday 15th December 2020

 

Applications will close when we have filled our virtual assessment centre dates.

 

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 2021!

 

1.            Eligibility Form

2.            Online Assessment

3.            Application Form

4.            Virtual Assessment Centre


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