8 Regulatory Affairs Manager jobs in Liverpool
Regulatory Affairs Manager
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Regulatory Affairs Manager - Pharmaceuticals
As the Regulatory Affairs Manager for the UK and Ireland, you will provide expert regulatory guidance to our UK organization and manage all regulatory activities across the UK and Ireland. Additionally, you will serve as the Local Person for Pharmacovigilance (LPPV) and the National Pharmacovigilance Contact Person.
We are a dynamic and innovation pharmaceutical company, dedicated to bringing groundbreaking therapies to markets. With several exciting drug launches planned over the next 24 months, we are looking for a dedicated and experienced Regulatory Affairs Manager to join our team.
Key Responsibilities:
- Provide UK regulatory expertise to the organization.
- Manage regulatory activities for the UK and Ireland.
- Serve as the LPPV/National Pharmacovigilance Contact Person.
- Ensure compliance with UK regulatory processes and national drug legislation.
- Support the launch of innovative drugs over the coming years.
- Liaise with regulatory authorities and maintain up-to-date knowledge of regulatory requirements.
Qualifications:
- Minimum of 5 years of experience in regulatory affairs within the pharmaceutical industry.
- Expert knowledge of UK regulatory processes and national drug legislation.
- Strong communication and organizational skills.
- Ability to work in a fast-paced environment and manage multiple priorities.
- Proven track record of successful regulatory submissions and product launches.
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Regulatory Affairs Manager
Posted 11 days ago
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Job Description
Regulatory Affairs Manager
I am working with a pharmaceutical/ Medical Device manufacturing site based in Deeside specialising in challenge meals, this is a good opportunity for a experienced Regulatory Affairs Manager to develop their career with an expanding company.
Key responsibilities for the Regulatory Affairs Manager
- Develop and implement regulatory strategies for FDA and MHRA submissions.
- Lead the preparation, submission, and lifecycle management of regulatory dossiers.
- Work closely with the director with FDA and MHRA, coordinating meetings, and inspection readiness.
- Monitor changes in global regulatory landscapes and assess impact on ongoing and future projects.
- Provide regulatory guidance during product development, labelling, and promotional review processes.
Requirements for the Regulatory Affairs Manager
- Bachelor's degree in a scientific discipline or a related subject.
- Minimum 5 years' experience in regulatory affairs, with demonstrable expertise in both FDA and MHRA regulatory processes.
- Strong knowledge of global regulatory standards
- Proven success in authoring and managing regulatory submissions and renewals.
- Excellent communication, leadership, and project management skills.
Benefits for the Regulatory Affairs Manager
- 25 holidays per year + Bank Holidays
- Christmas shutdown.
- Cycle to work scheme
- Private healthcare
- High street discount scheme
To apply for the Regulatory Affairs Manager or here more information, please contact Liam Shannon at Smart4Sciences on (phone number removed) or email me at
Regulatory Affairs Manager
Posted 26 days ago
Job Viewed
Job Description
Regulatory Affairs Manager
I am working with a pharmaceutical/ Medical Device manufacturing site based in Deeside specialising in challenge meals, this is a good opportunity for a experienced Regulatory Affairs Manager to develop their career with an expanding company.
Key responsibilities for the Regulatory Affairs Manager
- Develop and implement regulatory strategies for FDA and MHRA submissions.
- Lead the preparation, submission, and lifecycle management of regulatory dossiers.
- Work closely with the director with FDA and MHRA, coordinating meetings, and inspection readiness.
- Monitor changes in global regulatory landscapes and assess impact on ongoing and future projects.
- Provide regulatory guidance during product development, labelling, and promotional review processes.
Requirements for the Regulatory Affairs Manager
- Bachelor's degree in a scientific discipline or a related subject.
- Minimum 5 years' experience in regulatory affairs, with demonstrable expertise in both FDA and MHRA regulatory processes.
- Strong knowledge of global regulatory standards
- Proven success in authoring and managing regulatory submissions and renewals.
- Excellent communication, leadership, and project management skills.
Benefits for the Regulatory Affairs Manager
- 25 holidays per year + Bank Holidays
- Christmas shutdown.
- Cycle to work scheme
- Private healthcare
- High street discount scheme
To apply for the Regulatory Affairs Manager or here more information, please contact Liam Shannon at Smart4Sciences on (phone number removed) or email me at
Regulatory Affairs Associate
Posted 11 days ago
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Job Description
Regulatory Affairs Associate - 12 Month FTC - Cheshire (Hybrid) - up to 40,000 + Benefits - REF 1926
I am currently recruiting for a Regulatory Affairs Associate to work for a leading engineering organisation based in Cheshire, but on a hybrid basis. Salary up to 40,000 + Benefits.
The company are leaders within their field of expertise and are seen as the go to organisation within their specialist product area, not only in the UK, but on an international basis. They have multiple offices throughout the UK, as well as being strategically positioned throughout the world. They have gone from strength to strength over recent years and via organic growth as well as a range of acquisitions they have strengthened their client offering ensuring they stay at the forefront of the market.
To support the growth of the business they now have the need to appoint a Regulatory Affairs Associate on a permanent basis.
In this role as a Regulatory Affairs Associate, you will be responsible for the regulatory approvals on a global basis for a range medical devices. This will include the necessary documentation to support with the approvals process. You will also be involved in post market surveillance, vigilance reporting, field safety corrective actions (recalls) and risk management.
Essential Requirements:
- At least 2 years' experience as a Regulatory Affairs Associate or similar
- Experience with Post Market Surveillance
- Experience with vigilance reporting
- Experience with Field Safety corrective action (recalls)
- Previous experience with medical devices (ideally class II and class III)
Desirable Requirements:
- Risk management
This is a fantastic opportunity for a Regulatory Affairs Associate to work for a leader within their field. The company has very ambitious, but realistic growth plans and this role is part of the business's succession planning, so stability and progression are both on offer with this opportunity.
This is an immediate requirement so if you have the required skills and experience then please get in touch ASAP with an up-to-date copy of your CV. Either apply direct or contact Adam on (phone number removed).
Regulatory Affairs Associate
Posted 27 days ago
Job Viewed
Job Description
Regulatory Affairs Associate - 12 Month FTC - Cheshire (Hybrid) - up to 40,000 + Benefits - REF 1926
I am currently recruiting for a Regulatory Affairs Associate to work for a leading engineering organisation based in Cheshire, but on a hybrid basis. Salary up to 40,000 + Benefits.
The company are leaders within their field of expertise and are seen as the go to organisation within their specialist product area, not only in the UK, but on an international basis. They have multiple offices throughout the UK, as well as being strategically positioned throughout the world. They have gone from strength to strength over recent years and via organic growth as well as a range of acquisitions they have strengthened their client offering ensuring they stay at the forefront of the market.
To support the growth of the business they now have the need to appoint a Regulatory Affairs Associate on a permanent basis.
In this role as a Regulatory Affairs Associate, you will be responsible for the regulatory approvals on a global basis for a range medical devices. This will include the necessary documentation to support with the approvals process. You will also be involved in post market surveillance, vigilance reporting, field safety corrective actions (recalls) and risk management.
Essential Requirements:
- At least 2 years' experience as a Regulatory Affairs Associate or similar
- Experience with Post Market Surveillance
- Experience with vigilance reporting
- Experience with Field Safety corrective action (recalls)
- Previous experience with medical devices (ideally class II and class III)
Desirable Requirements:
- Risk management
This is a fantastic opportunity for a Regulatory Affairs Associate to work for a leader within their field. The company has very ambitious, but realistic growth plans and this role is part of the business's succession planning, so stability and progression are both on offer with this opportunity.
This is an immediate requirement so if you have the required skills and experience then please get in touch ASAP with an up-to-date copy of your CV. Either apply direct or contact Adam on (phone number removed).
Regulatory Affairs Specialist
Posted 1 day ago
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Job Description
We seek talented individuals who will contribute to and thrive in our collaborative, diverse, fast-paced environment while demonstrating a commitment to our core values, People, Customer, Results, Continuous Learning, and Innovation?
People - We win as a team?
Customer - We deliver customer-centric solutions?
Continuous Learning - We learn and always aim to be better?
Innovation - We innovate every day?
Results - Results matter for all of us.
Position Summary: This role manages the regulatory affairs function for Richard-Allan consumables and Shandon Diagnostic Instrumentation, ensuring regulatory compliance for Epredia's manufacturing site and device portfolios to support and maintain global market access. The Regulatory Affairs (RA) Specialist escalates all regulatory matters to the Global RA Director (Heather Gallacher) and is responsible for supporting global registration activities for instrument and consumable device portfolios.
What you will do:
Regulatory Support - Shandon Diagnostics & Richard-Allan Scientific:
+ Ensure regulatory compliance of the manufacturing site, supporting site operations accordingly.
+ Approve regulatory processes and documentation related to new product development, product changes, improvement projects, and marketing materials.
+ Support global product registration efforts for devices.
+ Prepare and maintain technical documentation including DoC, GSPR, and related files.
+ Contribute to the Health Hazard Assessment (HHA) process as part of Post-Market Surveillance (PMS) and Vigilance activities related to site complaints and quality issues.
+ Support the site's Quality Management System (QMS), including audits, regulatory SOPs, complaint investigations, and documentation/labeling review, approval, and release.
+ Lead regulatory activities for site projects, including new product development and manufacturing transfers.
+ Maintain regulatory intelligence at the manufacturing site s ; conduct training sessions as needed, including those on new regulations.
+ Complete EMEA registration requests for the instrument and consumable portfolio s (new and existing devices).
+ Complete or support registration requests across the entire Epredia portfolio, as needed
Qualifications & Skills:
+ Scientific degree with over 1 year of experience in In Vitro Diagnostic Medical Devices (IVDs).
+ Working knowledge of global regulations preferred (US FDA, EU IVDR, and Rest of World).
+ Spanish fluency (written and spoken) is beneficial not essential.
+ Strong attention to detail.
+ EMEA registration experience.
+ Clear and effective communication skills.
+ Ability to interpret and apply regulations to business-specific scenarios.
+ Competent in creating project plans, timelines, and regulatory strategies; skilled in organizing and tracking complex regulatory data.
+ Familiarity with ISO 13485 and global IVD regulations (US and EU).
+ Capable of managing multiple projects and competing priorities.
+ Exercises sound, ethical judgment within company policies and regulatory frameworks.
+ Willingness to travel internationally up to 10%.
TO ALL RECRUITMENT AGENCIES: Epredia does not accept unsolicited third-party resumes.
Building an Inclusive Culture: We are a company that brings the best people together and leverages their varying backgrounds, ideas, and points of view to invent on behalf of all customers. We are committed to equal employment opportunity for all individuals, without regard to race, color, national origin, ancestry, sex, age, religion, physical or mental disability, medical condition, veteran status, marital status, pregnancy, sexual orientation, gender identity, genetic information or any other protected classes which may exist under applicable federal, state or local law.
At Epredia, we improve lives by enabling better cancer diagnostics. We are a team of talented individuals with diverse backgrounds and expertise, working together to develop precision diagnostic solutions for our customers. We are a fast growing global company that drives innovation in diagnostics to create better outcomes for patients. Joining Epredia is much more than a job- it is an opportunity to be part of something with a purpose. Find out how you can improve lives while advancing your career.
Regulatory Affairs Specialist
Posted 1 day ago
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Job Description
Convatec Infusion Care is currently looking for a new colleague to join our dedicated Regulatory Affairs team. The RA department is responsible for Convatec Infusion Care product portfolio registration efforts and for ensuring local and worldwide regulatory compliance. You will be a part of a team of highly qualified and goal-oriented specialists who constantly aim at knowledge sharing, a high level of professionalism, and continuous improvement. While we set high standards for our work, we also strive for a healthy work-life balance and personal development. As our work is very dynamic, with many balls in the air at one time, you will have a unique opportunity to experience how a big corporation operates, conducts business, and has a positive impact on a global scale.
We offer you an impactful role in an innovative and far-reaching company. You will collaborate across the organisation and have a significant influence on the projects and processes assigned to you. Reporting to the Manager - Regulatory Affairs for the post Market activities, you will join a team of highly motivated employees. This position is located in Deeside, UK - with the flexibility of working from home when it fits with your tasks.
**Key Duties And Responsibilities**
+ Correspond with customers, appointed representatives in different countries and authorities regarding product registration;
+ Ensure that registrations fulfill regulatory requirements in relevant markets;
+ Maintain competence and knowledge regarding product registration and regulatory requirements in relevant markets ensuring that the impact of new regulations and changes in regulations are assessed and communicated within the organization, as required;
+ Obtain knowledge of regulatory requirements to develop regulatory strategies for product launch and support registration in new markets;
+ Provide regulatory support across the organization to ensure that the regulatory requirements are met, and that relevant product documentation is in place as required by regulatory authorities during the different stages of the product life cycle;
+ Ensure that documents are generated and maintained for the registration of new devices, changes to existing products, and notification of said changes to the regulatory authorities. These documents include but are not limited to Declarations of Conformity, Technical File Summaries, regulatory statements, etc;
+ Ensure maintenance of procedures and instructions related to Regulatory Affairs;
+ Maintain regulatory Information in relevant databases;
+ Ad hoc assistance within the regulatory field;
+ Assess regulatory impact for changes to existing as well as new products;
+ Sign documents related to products registration, according to the relevant procedures governing each document and in line with the responsibilities described above;
+ Sign documents related to the development of new products and changes to existing products;
+ Prepare, review, and sign Regulatory Assessment Plans.
**About You**
We are looking for a structured, positive, and team-oriented specialist. Additionally, you possess excellent communication and project management skills, along with comprehensive knowledge of worldwide regulations and MDR.
As a person who looks for solutions rather than obstacles, you take pride in being a specialist and aim to improve your personal and professional skills. You understand that the key contributing factor to success is collaboration with your closest colleagues and across functions. Delivering high-quality, timely solutions, and projects are top priorities for you. Having a strong grasp of good documentation practice, and habits of working in a structured and methodical manner, you know when to execute and delegate.
To be truly successful in this position you must enjoy cooperating within large project groups and having a busy workday while managing several tasks at the same time. You are fluent in English, in writing as well as verbally, as the company language is English.
**Your Qualifications And Experience**
+ Engineer or technical/bachelor degree as Pharmaconomist, Laboratory technician, or relevant work experience (required)
+ Customer service experience (preferred)
+ Work experience with product registration/market access of medical devices or pharmaceuticals (preferred)
+ Fluent English, verbal and written (required)
+ Familiar with commonly used computer software packages
+ Knowledge of regulations related to product registration (required)
+ Knowledge of ISO 13485 or similar regulations, (preferred)
Our transformation will change your career. For good. You'll be pushed to think bigger and aim for excellence. Your ideas will be heard, and you'll be supported to bring them to life. There'll be challenges. But, stretch yourself and embrace the opportunities, and you could make your biggest impact yet. This is stepping outside of your comfort zone.
This is work that'll **move** you.
#LI-AN1
#LI-Remote
**Beware of scams online or from individuals claiming to represent Convatec**
A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.
If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you're unsure, please contact us at .
**Equal opportunities**
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.
**Notice to Agency and Search Firm Representatives**
Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
**Already a Convatec employee?**
**If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you!**
Regulatory Affairs Coordinator
Posted today
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Job Description
Great British Energy-Nuclear (GBE-N) is a new government arm's length body supporting the delivery of Britain's energy security and net zero, making sure that we can power Britain from Britain sustainably. It has been set up to turn nuclear ambition into reality.
GBE-N's first step was to start the technology selection process for Small Modular Reactors (SMRs). SMRs can potentially be quicker to deploy and less expensive to build than traditional nuclear power plants because they are smaller, have factory based modular manufacturing, and more flexible deployment options.
GBE-N is aiming to deliver fast, based on a supportive and collaborative culture which values equality and diversity and creates an inclusive workplace. It draws on deep nuclear expertise - its Executive Committee has over 100 years of nuclear experience in this country and abroad. And it can unlock billions of pounds of private and public investment from design to operation, helping to get sites ready for development, and working to grow manufacturing capacity and skills capability.
Our activities will be driven by our values, which are:
Trust - We prioritise safety , we act responsibly and with integrity .
Collaborative - We work as a team ; we value diversity and expertise .
Challenge - We are curious and courageous in the way we think and act .
Care - We are thoughtful , inclusive and respectful of others.
Drive - We get things done and we make a difference .
If you have a disability and would prefer to apply in a different format or would like us to make reasonable adjustments to enable you to apply or attend an interview, please contact us at and we will talk to you about how we can assist.
Job profile:
Join GBE-N and help shape the future of UK energy. We're looking for a Regulatory Affairs Coordinator to support the delivery of nuclear energy projects aligned with government policy.
In this key role, you'll coordinate regulatory engagement across government, industry, and regulators, helping to develop strategies and procedures that enable successful project delivery. You'll support licensing, permitting, and consents across GBE-N projects, and help drive consistency and efficiency in regulatory processes.
Responsibilities:
- Coordinate engagement with regulators, industry, and government.
- Support development of regulatory strategies and programme plans.
- Maintain consistent procedures for consents, licensing, and permitting.
- Organise meetings, prepare documentation, and manage digital records.
- Assist with regulatory submissions including planning and environmental permits.
Knowledge, Skills and Experience:
- A degree in planning, engineering, or a nuclear-related discipline.
- Experience in nuclear project delivery and regulatory processes.
- Strong communication, organisation, and stakeholder management skills.
- Proficiency in digital tools (SharePoint, MS Teams, Word, Excel, PowerPoint).
- Adaptability and a collaborative mindset in a fast-changing environment.
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Principal or Senior Consultant / Engineer: Local Government Flood Risk Management and Sustainable...
Posted 1 day ago
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At WSP, you can access our global scale, contribute to landmark projects and connect with the brightest minds in your field to do the best work of your life. You can embrace your curiosity in a culture that celebrates new ideas and diverse perspectives. You can experience a world of opportunity and the chance to shape a career as unique as you.
To find out more about our Water business click on the following link and discover what awaits you at WSP:?Water Resilience | Stronger Together | WSP ( to strong and sustained growth in our Sustainable Water Management business, we are seeking experienced applicants to join our team of 300 water science and engineering professionals. Applicants are invited to further strengthen our project delivery and technical capability in a wide range of flood risk management projects for our Local Authority clients.
The Sustainable Water Management business operates as a national team and work is shared around the team in a fair and transparent way, ensuring project allocation takes into account personal interests and development aspirations and much as practicable.
**A little more about your role.**
We are looking for passionate professionals who have a strong experience working with Lead Local Flood Authorities and have a competent understanding of key legislation and policies such as the Flood and Water Management Act, The Land Drainage Act and the National Planning Policy Framework (in relation to flood risk and drainage). With preferred strengths in flood risk management and sustainable drainage you will ideally have familiarity with other water environment disciplines to aid delivery of more complex projects for a range of clients.
The appointment would be at Senior or Principal grade, depending on experience. We can be flexible on location within the UK and offer a true hybrid work arrangement.
You will contribute to a diverse range of projects but the main focus of your work is likely to be delivering and taking technical lead roles on flood risk management projects for local authorities which can include large range of projects including; flood investigations, developing flood strategies, helping deliver solutions for flood alleviation, natural flood management, sustainable drainage master-planning, and supporting the planning process to ensure the most sustainable solutions are achieved for the water environment.
Your work will be varied but will include some technical, management and commercial responsibilities. Sharing your technical expertise and mentoring others in the team will also be an important part of your role.
**Responsibilities will include:**
+ Significantly contributing to delivery of good quality technical deliverables to clients, often as technical reviewer.
+ Supporting and mentoring junior colleagues, overseeing small project teams.
+ Managing workload and project delivery with minimal supervision.
+ Demonstrating positive H&S behaviours and championing this amongst the wider team.
+ Contributing to the planning of tasks/projects providing input to programme, budget, and quality requirements.
+ Engaging positively and professionally with clients and developing trusted advisor role as you grow a network of client contacts, supported by more senior colleagues.
+ Contribute to securing small projects and extensions to existing projects.
+ Develop solutions that address client issues, challenges, and needs in collaboration with project or team leaders.
**What we will be looking for you to demonstrate.**
**Skills / Experience**
+ Experience working in flood risk management with local authorities or a combination of public and private sector flood risk management experience.
+ Demonstrable experience of understanding budgets and leading delivery of projects or technical outputs related to flood risk management or sustainable drainage.
+ Understanding of the Flood and Water Management Act 2010, the Land Drainage Act the Planning Practice Guidance: Flood Risk and Coastal Change and its application for management of flood risk for Local Authorities in the UK. Desirable wider knowledge of the regulatory context for planning in the UK.
+ Excellent communication and interpersonal skills. Experience in supporting and/or mentoring more junior colleagues whilst having the ability to successfully liaise with more senior colleagues when needed.
+ Knowledge and understanding of surface water drainage modelling and Sustainable Drainage Systems.
+ Experience in preparing Local Flood Risk Management Strategies and Strategic Flood Risk Assessments.
+ Demonstrable experience in technical report writing and checking.
+ Confidence in presenting and leading meetings with team members and clients.
**Qualifications**
+ A degree in a relevant environmental, geographical, science or engineering discipline is essential
+ Chartered status with C.WEM, CEnv, CSci or CEng is desired for Principal or evidence of working towards chartership for Senior
Don't quite meet all the criteria? Apply, and we can see how your experience aligns to this role and other opportunities within the team
**Imagine a better future for you and a better future for us all.**
Join our close-knit community of talented individuals who share your passion for making a positive impact. Our global team includes more than 69,000 employees, working together to make a difference in communities both close to home and around the world.
**With us, you can.** **Apply today.**
#LI-ES1
We are one of the world's leading engineering and professional services firms. Our 72,800 passionate people are united by the common purpose of creating positive, long-lasting impacts on the communities we serve through a culture of innovation, integrity, and inclusion. With over 9,000 professionals across the UK and Ireland, we are dedicated to our local communities and propelled by international brainpower.
**WHAT'S IN IT FOR YOU?**
**Work-life balance**
At WSP, we understand that work is just one aspect of your life. It's important to make time for you, your family, friends, interests and your community.
Our hybrid working policy offers the flexibility to work from home two days a week, while also providing opportunities to collaborate in our modern offices across the UK.
**Inclusivity & Belonging**
We welcome applicants with varied backgrounds and experiences. We enable rewarding careers by encouraging people to bring their whole and authentic selves to work so that our work represents the fullest spectrum of society. We celebrate integrity and treat people with respect, supporting each other and embracing a culture of inclusion and belonging at WSP. We have our employee resource groups bring together employees and allies with different backgrounds to promote our culture of inclusivity.
**Health & Wellbeing**
We are committed to supporting our people, giving you the tools to make improvements to your health and wellbeing through our Thrive programme.
Our Virtual GP service gives you access to an NHS or Irish Medical Council GP at a time and place that suits you - giving you peace of mind and quick access to medical advice when you need it most. We also provide reasonable workplace adjustments for those in need. Additionally, you can benefit from the Gymflex scheme, which offers up to 40% off annual gym memberships through our WSP flexible benefits program, as well as a comprehensive menopause support package.
**Flex your time**
To enhance work-life balance, WSP offers the "WSP My Hour," allowing you to take one hour each day for personal activities, with the flexibility to make up the time earlier or later that day.
We also provide part-time and flexible working arrangements, the option to purchase additional leave, and the ability to use your bank holiday entitlement to suit you.
**Your development**
We understand the importance of development and training to you. That's why we foster a supportive environment that invests in your growth, whether through training, mentoring, or Chartership.
**#WeAreWSP**
_Here at WSP we positively encourage applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, pregnancy or maternity/paternity. As a Disability Confident leader, we will interview all disabled applicants who meet the essential criteria, please let us know if you require any workplace adjustments in support of your application._