Regional Regulatory Affairs (Oral Health R&D) Placement

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Regional Regulatory Affairs (Oral Health R&D) Placement

A career in Oral Health R&D where none of us stand still.

Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question.

This is an exciting time to join us and help shape the future. It’s an opportunity to be part of something special.

Are you interested in ensuring that products classified as cosmetics, pharmaceutical medicines, food 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 healthcare 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 6 distinct roles available within Regulatory Affairs and we are recruiting for all roles within this advert. When you apply you will be able to select 3 preferences. We will accommodate your preferences where possible. They are:

Global Oral Heath Regulatory Affairs Associate Innovation - new product introductions (2 positions) Global Oral Heath Regulatory Affairs Associate Lifecycle and CMC (Chemistry, Manufacturing and Controls) - maintenance of Consumer Healthcare dossiers post licence (1 position) Product Lifecycle Management (PLM) Regulatory Affairs Associate (Non-Medicinals) - licence renewals, , periodic safety assessment reports, licence cancellation requests and new product introduction support (1 position) Product Lifecycle Management (PLM) Regulatory Affairs Associate (Medicinals) - licence renewals, administrative variations, periodic safety assessment reports, licence cancellation requests and new product introduction support (1 position) Regulatory Affairs Executive, Great Britain & Ireland - local market role (1 position) Regional Regulatory Affairs Associate (EU) – innovation and maintenance for Medical Devices (1 position)

What will your individual contribution at Haleon be?

1. Global Oral Heath Regulatory Affairs Associate Innovation

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 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, 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 Haleon’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.

2. Global Oral Heath Regulatory Affairs Associate
Lifecycle and CMC (Chemistry, Manufacturing and Controls)

The purpose of this role is to provide regulatory support to post licensed 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 information on the formulation, manufacturing process, 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 updating the Regulatory Systems. Updating the dossier involves the process of categorising the changes into distinct 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 timeframe, 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 project Teams, to ensure all regulatory requirements are met for both all existing consumer health products (within the Oral Health Category) according to Haleon Values.

All-in-all, this job gives not only gives you an opportunity to hone your scientific skills but also helps develop your analytical, logical, and strategic qualities.

3&4. Product Lifecycle Management (PLM) Regulatory Affairs Associate (Non-Medicinals and Medicinals)

The purpose of this role is to provide Global regulatory support to an assigned portfolio / product / project to enable Haleon 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, classification types and therapeutic areas.

The PLM team are responsible for the following activities.

Prepare/ensure availability of high-quality documents required to support maintenance activities of product licences are completed globally, for:

• Renewals;
• Periodic Safety Assessment Reports;
• Administrative Variations;
• Licence Cancellation Requests;
• New Product Introduction Support.
• Manage the execution and delivery of ‘Right First Time’ dossiers, ensuring filings for planned initiatives are completed as planned and in accordance with market data requirements.

Partner with all associated stakeholders, i.e. CMC, Category, Clinical, Medical, Safety, Local Regulatory to manage the execution and delivery of ‘Right First Time’ dossiers, ensuring filings for planned initiatives are completed as planned and in accordance with market data requirements.

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 Haleon’s consumer health products around the world.

5. Regulatory Affairs Executive, Great Britain & Ireland

Within this local market Regulatory role, you’ll play a key role in managing many of our trusted global brands, across Oral Health, Pain Relief, Respiratory, Skin Health, Gastrointestinal Health and Wellness, on brands such as Panadol, Sensodyne, Aquafresh, Beechams and Centrum.

The role will give you responsibility and involvement in a wide range of projects related to currently marketed and new innovation products. You will also gain experience across a variety of product classifications, such as Cosmetics, Medical Devices, OTC Medicines and Food Supplements.

Key responsibilities include:

• Ensuring cosmetic products and medical devices are sold in compliance with the relevant directives or regulations
• Ensuring that all pack and promotional copy complies with relevant regulations and Codes of Practice
• Preparing accurate, high-quality submissions and ensuring all files and databases are effectively managed
• Providing advice to marketing and supply chain on the regulatory implications of technical changes
• Working collaboratively within a multi-functional team
• Responding to queries/complaints raised by consumers and healthcare professionals, and documenting reported adverse events
• Maintaining relationships with external regulatory authorities/bodies to ensure the smooth and timely assessment of all applications

6. Regional Regulatory Affairs Associate (EU) – Innovation and maintenance for medical devices

The purpose of this role, within the EU Region, 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. You will support the Regulatory Affairs EU Regional 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.

To recognise your dedication, energy and effort, benefits include:

• A salary of £22,500
• An annual bonus linked to performance
• Employee recognition through our global scheme which rewards exceptional achievements
• On-the-job experience and formal and informal training and development, delivered through a mixture of coaching, mentoring and formal training programmes
• Health and wellbeing programmes to take care of your physical and mental health

We’re the people changing the future of everyday health.

So you will be someone who has:

• Creative and problem-solving thinking
• Strategic/big-picture thinking
• Entrepreneurial and agile mindset
• Strong prioritisation and analytical skills
• Personal accountability
• Business and consumer/customer knowledge and understanding
• Adaptability and resilience in ambiguity
• A desire to learn and have meaningful impact

To enable you to perform in this future talent opportunity:

Education required:

You will have completed a minimum of 2 years of your undergraduate degree in science but will not have graduated at the start of your placement.

For all of the following roles in Regulatory Affairs you’ll need:

• good communication skills (written and verbal)
• attention to detail
• the ability to adapt to change and stay focused under pressure etc.

Other requirements:

If you have the following characteristics, it would be a plus:
Expertise in using IT systems

Diversity, Equity and Inclusion

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone.

We’re striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives.

We flex the way we work so we can be at our best, where possible, and with agreement between line manager, team and individuals. We acknowledge not all colleagues can flex locations depending on their roles and that we don’t have all the answers... Yet.

We invite you to apply as soon as possible. The way we see it, every day is an opportunity. And we are joined by new talent, every day. We accept ongoing applications and will close this vacancy once we have enough applications.

Assessment centre dates: Assessment centres/interviews will commence from November onwards

About Haleon

We are Haleon. Our portfolio of category-leading brands previously formed the Consumer Healthcare division of global biopharma company GSK. As of Monday 18 July 2022, Haleon began its journey as an independent, global leader which is 100 per cent focused on everyday health.

In front of us is an incredible opportunity. To deliver better everyday health with humanity. An invitation to make it more achievable, more inclusive, and more sustainable. Together, weʼre empowering millions of people worldwide to take more control of their own health. To do this, each of us is committed to building on our global portfolio of category-leading brands like Sensodyne, Panadol and Voltaren.

To combine our trusted science with deep human understanding. And to take us beyond everything weʼve done before.

Early talent roles at Haleon offer the chance to change the way people see and manage their everyday health. Itʼs a unique opportunity. An exciting challenge. And a huge responsibility. Weʼre always looking for ambitious apprentices, students and graduates who are inspired by our purpose and share our passion for helping people make a difference to their everyday health.

How to apply

To apply for this role and to find out more, please click on the apply button.

Applications may close before the deadline, so please apply early to avoid disappointment.

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