148 Legislation jobs in the United Kingdom

VEX Legislation Specialist

Cheshire, West Midlands £35 - £45 Hourly Matchtech

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Job Description

contract

Our client, a leading player in the automotive sector, is currently seeking a VEX Legislation Specialist on a contract basis. This position serves as the key communication link and first point of contact between the legislation team and the R&D functions. The VEX Legislation Specialist will work collaboratively with developers and legislative experts to understand and communicate the technical implications of new or amended legislation.

This role can be Outside IR35

Previous experience with international law in Connectivity field, data protection & Telematics in the Automotive domain.



Main Responsibilities:

  • Distributing regulatory and legislative information to the affected engineers or functional managers.
  • Assessing and interpreting new or amended legislation in consultation with the VKO, department FO, and subject matter experts.
  • Providing feedback from departments to the VKO after consultation with engineers concerning legislation.
  • Establishing and maintaining networks across the company and with expert bodies to clarify the impact and resolve open points in the legislation.
  • Establishing and maintaining Project Specific Legislation Roadmaps (PSLR) in line with PEP gateways.


Job Requirements:

  • Experience working within the automotive industry or a related sector.
  • Experience in vehicle development programs, from launch through to production.
  • Strong communication and influencing skills, with the ability to build positive relationships.
  • Leadership and facilitation skills for resolving inconsistencies in legislation or its interpretation.
  • Strong technical understanding of vehicle regulation and legislation, with the ability to coach or guide others effectively.
  • Ability to absorb technical documentation and extract key information for presentation or communication.
  • Good business awareness and the ability to make and influence strategic decisions within a business context.
  • Good knowledge of engineering or regulatory processes with an established network of contacts in the field.
  • Capability to act as a contact for engineers who have questions about vehicle legislation or regulations in relation to their designs.
  • Understanding and ability to demonstrate behaviours in line with the company's People Framework.


If you have the required expertise and are ready for an exciting new challenge in the automotive industry, we encourage you to apply now to join our client's dedicated team as a VEX Legislation Specialist.

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Legislation Engineer Specialist

Cheshire, North West Contechs Consulting

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Job Description

contract

Position: VEX Legislation Specialist

Sector: Electrical

Location: Crewe

Position Type: Contract

Outside IR35, 37 hours per week

*Applicants MUST have proof of immediate, on-going and valid eligibility to work full time in the UK and travel within the EU.*

I am currently recruiting on behalf of a premium automotive manufacturer who are looking for a VEX Legislation Specialist to join their team on a long term rolling contract basis.

Job Description

As VEX Legislation Specialist your main responsibilities are:

  • Distribute regulatory / legislative information within their own department to the affected Engineers or / Functional Managers.
  • Assess and interpret new or amended legislation to determine its applicability by consulting with the VKO, FO the department and subject matter experts.
  • Responsible for providing feedback from departments, to the VKO, after consultation with Engineers in relation to legislation.
  • Establishes and maintains networks across the Client and group VEX / VKO or other expert bodies, as appropriate, to clarify impact and resolve open points in the legislation.
  • Establishes and maintains Project Specific Legislation Roadmaps (PSLR) in line with PEP gateways.

Qualifications / Skills needed

  • Experience of vehicle development programs from launch through to production.
  • Leading & facilitating working groups to resolve inconsistencies in legislation, its interpretation or opinions.
  • Strong technical understanding of vehicle regulation / legislation with an ability to coach or guide others effectively.
  • Good business awareness and ability to make and influence strategic decisions within business context.
  • Good knowledge of Engineering or regulatory processes with an established network of contacts in the field.
  • Understanding and ability to demonstrate behaviours in line with the Clients' People Framework.

Why work through Contechs?

Contechs is a leading Automotive, Design, Engineering, Technology and Innovation Recruitment Consultancy. Founded in 1997, with an inhouse Contractor Care Team to support all external employees, acts as an employment agency for permanent and contract recruitment.

How to Apply

If you're interested in applying for this position, submit your application and one of our recruiters will be in touch.

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Vex Legislation - Product data and Tell tales

Cheshire, West Midlands £36 - £46 Hourly Adecco

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Job Description

contract, temporary

Join Our Team as a VEX Legislation Expert!
Are you ready to drive innovation in the automotive industry? Adecco working in partnership with Bentley Motors are searching for a dynamic VEX Legislation Expert to join their Connected Car R&D portfolio planning team. This is an exciting opportunity for someone enthusiastic about connected car technology and eager to shape the future of vehicle features and customer experiences.

Pat rate: PAYE: 37.06 LTD: 45.58
Current End Date: 23/12/2025 - will be extended
Working Pattern: 37 hours per week, Hybrid - 3 days onsite per week, Bentley core hours
Location: Pyms Lane, Crewe, CW1 3PL

Key Responsibilities:
* Serve as the primary communication link between the legislation team and R&D functions.
* Distribute regulatory information to engineers and functional managers, ensuring everyone is informed and compliant.
* Assess and interpret new or amended legislation, collaborating with subject matter experts to determine applicability.
* Provide timely feedback to the VKO after consulting with engineers.
* Establish and maintain networks across the organization to clarify legislative impacts.
* Develop and maintain Project Specific Legislation Roadmaps (PSLR) in alignment with PEP gateways.

What You Bring to the Table:
* Experience: Proven background in the automotive industry with firsthand experience in vehicle development programs from launch to production.
* Communication Skills: Strong ability to communicate and influence, fostering positive relationships across teams.
* Technical Understanding: Deep knowledge of vehicle regulations and the ability to guide others effectively.
* Business Acumen: Good awareness of business processes, enabling you to make informed strategic decisions.
* Collaboration: Experience in leading working groups to resolve legislative inconsistencies and interpretation challenges.
* Documentation Skills: Ability to absorb technical documentation and distill key information for clear communication.

Qualifications:
* Minimum degree level education, preferably in engineering.
* Familiarity with vehicle regulatory processes and development lifecycles.

Join a team that values innovation and compliance, where your expertise will directly impact the future of automotive design and safety. If you are ready to take on this exciting challenge and help shape the future of vehicle legislation, we would love to hear from you!

How to Apply:
If you meet the qualifications and are excited about this opportunity, please submit your application today! Your journey towards making a significant impact in the automotive industry starts here!
Be the driving force behind compliance and innovation. Join us and let us pave the way for the future of automotive legislation together!

Please note if you do not hear back regarding your application within 5 working days you have unfortunately been unsuccessful currently, but we thank you for your interest.


Adecco is a disability-confident employer. It is important to us that we run an inclusive and accessible recruitment process to support candidates of all backgrounds and all abilities to apply. Adecco is committed to building a supportive environment for you to explore the next steps in your career. If you require reasonable adjustments at any stage, please let us know and we will be happy to support you.

Adecco acts as an employment agency for permanent recruitment and an employment business for the supply of temporary workers. The Adecco Group UK & Ireland is an Equal Opportunities Employer.

By applying for this role your details will be submitted to Adecco. Our Candidate Privacy Information Statement explains how we will use your information - please copy and paste the following link in to your browser (url removed)

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Regulatory Affairs Manager

Headington, South East £50000 - £65000 Annually CY Partners

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Job Description

permanent

Regulatory Affairs manager – Medical Devices

A new role in Regulatory Affairs has become available at an exciting medical devices organisation who have products undergoing clinical trials. The role focuses on FDA and UK/EU submissions

As an experienced Regulatory Affairs professional, you’ll manage and prepare regulatory submissions (e.g., variations, renewals, new market applications) and ensure compliance with U.S. (FDA) and European (EMA) regulations. Key responsibilities include strategic planning, cross-functional coordination with manufacturing, quality assurance, regulatory writing and document review, and liaising with health authorities. 

The company has exciting medical device products currently undergoing clinical trials. Head office is based in Oxfordshire.

Key Responsibilities

  • Submission Strategy:  

Developing strategic plans for regulatory submissions, including variations, renewals, and new market applications. 

  • Document Preparation:  

Writing, reviewing, and ensuring the accuracy and compliance of submission documents, such as Chemistry, Manufacturing, and Controls (CMC) data, study reports, and other regulatory materials. 

  • Regulatory Compliance:  

Ensuring all submissions and regulatory activities meet the requirements of the FDA (U.S.) and European Medicines Agency (EMA). 

  • Cross-Functional Coordination:  

Collaborating with internal teams (manufacturing, quality assurance, quality control, etc.) and external partners to gather necessary information for submissions. 

  • Authority Interaction:  

Communicating with health authorities (e.g., FDA, EMA) regarding submissions, queries, and regulatory matters. 

  • Post-Approval Maintenance:  

Managing ongoing regulatory activities such as post-approval variations, annual reports, and changes to product manufacturing. 

Required Skills & Qualifications

  • Regulatory Knowledge:  In-depth understanding of FDA and EU regulatory requirements for pharmaceutical products or medical devices. 
  • Technical Skills:  Proficiency in regulatory document management systems and MS Office applications. 
  • Communication:  Strong written and verbal communication skills in English. 
  • Project Management:  Ability to manage multiple projects, meet deadlines, and prioritize tasks effectively. 
  • Collaboration:  A collaborative team player with cultural awareness and adaptability. 

This is an exciting opportunity at a growing medical devices organisation. The facility is based in Oxfordshire and offers hybrid working opportunities.

We look forward to receiving your application.

CY Partners is acting as an Employment Business / Agency in relation to this vacancy.

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Regulatory Affairs Consultant

Berkshire, South East SRG

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Job Description

temporary

Job Title: Regulatory Affairs Consultant

Location: Maidenhead

Contract: 12 months / hybrid 3 days onsite

Hours: 37.5 per week

Rates: 50-60p/h

Job Description

SRG are looking for a regulatory affairs consultant to join a leading pharmaceutical company based in maidenhead. As part of this role, you will be Supporting lifecycle management of applicable products or submissions, management of paediatric investigation plans and clinical trial activities with the Medicines and Healthcare Products Regulatory Agency (MHRA).

Duties and Responsibilities

Overall responsibilities

With supervision and guidance from Line Manager;

  • Acts as the primary Regulatory contact for identified portfolio.
  • Develops robust regulatory strategies and timelines for those products throughout their lifecycle and provides regulatory information updates to cross functional team.
  • Develops and maintains relationships with cross functional partners, as well as the Area Regulatory team to advocate the UK strategy objectives and timelines through the Area Regulatory Project Team.
  • Serves as Health Authority liaison and interface for Health Authority meetings to obtain optimal outcomes for patients and company portfolio.
  • Supports the business in planning for and execution of product launches, acquisitions and divestitures, as required.
  • Regulatory intelligence and external landscape monitoring - provides regulatory impact assessment and establishes best practice

Main Accountabilities

  • Supports Area and Brand teams as required to ensure local strategy is considered and that the key regulatory messaging is understood.
  • Ensures submission and content of MHRA new and product lifecycle applications are made in accordance with appropriate timings and requirements
  • Ensures appropriate and timely communication of regulatory and safety information as required by local regulation, company policies and procedures
  • Keeps up to date with all appropriate Regulatory issues and operate as a 'problem-solver', to provide effective resolution of regulatory issues occurring within the UK, with an appreciation of business needs and priorities and will escalate to the Director, Regulatory Affairs as necessary.
  • Builds business relationships with key internal stakeholders, including Europe region Regulatory Affairs, Medical Affairs, Market Access, Commercial and QA, as required to enable good cross-functional working.
  • Stays abreast of all Regulatory intelligence updates and is proactive regarding implementation of necessary legislation/regulation changes.

Experience and Qualifications

  • Life Sciences Degree or equivalent experience
  • Varied experience within UK or EU Regulatory Affairs, including clinical trials, paediatric investigation plans, license lifecycle management
  • Excellent communication skills, both verbal and written
  • Effective influencing, tactical and presentation skills
  • Effective project management experience
  • Consultative and collaborative interpersonal style
  • Excellent English language skills
  • The ability to thrive in a changing environment and to re-prioritise workload to meet business needs.

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.

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Regulatory Affairs Manager

Berkshire, South East SRG

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temporary

Job Title: Regulatory Affairs Manager

Location: Maidenhead

Contract: 12 Months / Hybrid 3 days per week onsite

Hours: 37.5 hours per week

Rates: 80-90p/h

Job Description

SRG are seeking a regulatory affairs manager for a leading pharmaceutical company based in Maidenhead. For this role you will be working in collaboration with line manager and/or Area Product Lead, is responsible for implementation of registration strategy to ensure the regulatory approval of commercially successful pharma products in the Europe region. Is responsible for ensuring effective product maintenance and lifecycle management, in line with legal/regulatory requirements and regional business needs. May also support European regulatory strategy for assets in development.

Duties and Responsibilities

In consultation with line manager and/or Area Product Lead;

  • Provides clear and constructive Europe Region (Area) regulatory input and intelligence to Area and Global Regulatory & Development Project Teams via the Area and/or Global Regulatory Lead (GRL) in accordance with Area & Commercial objectives.
    • Ensure planned drug development activities comply with Area guidelines and if they do not provide a critical analysis of the risks and issues with a remediation proposal.
    • Support global product development strategy(s); outlining options for Scientific Advice/PIP/IMPD, coordinating preparation of briefing packages and co-ordinating and leading agency meeting preparation.
    • Prepare strategy recommendations to global regulatory and development teams in order to shape the global product strategy in line with Area regulatory and commercial objectives
  • Define & implement Area filing strategy (including CP, MRP, DCP); identifying risks and proposing mitigation.
  • Lead, plan, conduct and implement regulatory activities in support of lifecycle maintenance in Area. Identify compliance risks and remediation activities proactively.
  • GRPT & ARPT representative ensuring regulatory requirements/interests of Area & Affiliate are represented at GRPT
  • Supports co-ordination of the review of CMC, QRD, PSUR and labelling submissions and approval of product-related packaging as required to ensure regulatory compliance.
  • Interface with EMA or Area Health Authority(s) for products within the Therapeutic Area on behalf of the Product Lead when required.
  • Responsible for ensuring effective planning and tracking of activities, especially submissions and key correspondence. Ensures effective planning and tracking of activities via internal tools
  • Supports co-ordination of the review of CMC, QRD, PSUR and labelling submissions and approval of product-related packaging as required to ensure regulatory compliance.

People

  • Establishes strong and effective relationships with affiliates, area and global regulatory teams as well as cross-functional teams thereby ensuring RA activities are in line with regional business priorities.
  • Potential to mentor less experienced Area regulatory colleagues as required


Processes

  • Follows Global Regulatory policies and procedures.
  • Ensures that new processes are developed and implemented in order to leverage the global infrastructure and maximise efficiency, ensures that new processes are aligned with global policies, but also meet regional regulations and needs.
  • Responsible for the Notification of Regulatory activities and RIM system entry/data accuracy for allocated projects.
  • Responsible for ensuring forecasts are developed and actuals managed in line with regional requirements and communicating these to Area TA Head, GRL and R&D finance for assigned projects.

Experience and Qualifications

  • Graduate in Life Sciences in a relevant area.
  • Sound knowledge of both pharmaceutical regulations and guidelines and national regulations within Area.
  • Pharmaceutical industry experience in European Regulatory strategy development and regulatory procedures, EU centralised procedure essential. Experience of EU strategy for development assets e.g. scientific advice, paediatric investigation plans preferred.
  • Experience working effectively across cultures and in complex matrixed environment.
  • Excellent organizational skills and solution driven leadership style

Essential Skills and Abilities

  • Ability to prioritise and manage workload including managing multiple projects.
  • Ability to work effectively and collaboratively across the organisation.
  • Experienced in working effectively across cultures and in complex matrix environment.
  • Good interpersonal and negotiation skills and the ability to influence others.

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.

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Regulatory Affairs Officer

Berkshire, South East Park Street People

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Job Description

permanent

Are you passionate about regulatory affairs and eager to help life-changing medical products reach the market? Our client is looking for a Regulatory Affairs Officer to support their team in guiding pharmaceutical, medical device, cosmetics and life sciences companies through complex regulatory landscapes.

Whilst part of a team, you will work independently. Aside from regulatory submissions, you will engage with clients providing regular updates and advice on projects. This is a great opportunity to further develop your regulatory knowledge and consulting skills.

Key Responsibilities

  • Assist in preparing and submitting regulatory documents for UK, EU and US markets mainly on medical devices
  • Support clinical trial processes, registries and Post-Market Clinical Follow-up studies
  • Research evolving regulatory frameworks to keep strategies cutting-edge
  • Provide updates, presentations and regular communication with clients across multiple time lines
  • Work alongside senior consultants to develop tailored compliance solutions


Requirements

  • A degree in Life Sciences, Pharmaceutical Sciences, Regulatory Affairs or a related field
  • An understanding of clinical trials, registries, and PMCF requirements
  • Experience liaising with regulatory authorities and clients and presenting detailed reports to them
  • Familiarity with global regulatory bodies and frameworks
  • Strong IT skills and attention to detail
  • Excellent communication and problem-solving abilities

Park Street People Ltd is an Equal Opportunities Employer. We do not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and comply with all relevant UK legislation. We are acting as an Employment Agency in relation to this role.

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Regulatory Affairs Specialist

Hertfordshire, Eastern £40000 - £55000 Annually ARx Recruitment Services

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permanent

What does 'family business' mean to you?

For some, it's code for small, for others it is a collaborative and friendly space.

The truth - it's usually both.

Family, small to midsized pharmaceutical companies look after their staff. You become part of their community, their culture, and the way they do things.

In our experience, staff at family run SMEs experience longer levels of employment than at large global corporations, and are often compensated well over time for their rewards.

Which is why, I am delighted to be representing a leading (family run) pharmaceutical manufacturing organisation based near Watford in the UK.

This amazing company are going through a great transformation that should ensure the company's future for generations to come, and as part of that they are looking for reliable, professional and hard working Regulatory Affairs professionals.

As part of this expansion, our client is looking for someone with 5+ years experience in Pharmaceutical Regulatory Affairs (ideally in a similar style of company, but they are open to people from all different pharmaceutical organisations).

You need to have a hard working attitude, good attention to detail, and you need to be able to work well with your team. Your experience in eCTD manager and document management tools will be valued, and you will need knowledge of global Regulatory requirements and guidelines (MHRA, EMA and ICH).

This is a site based role near Watford (5 days per week) and would suit someone looking for a company they can grow with, and build with, and that will give them huge career tragectory in a culture that is supportive and dynamic.

Interested? Apply Now!

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Regulatory Affairs Executive

Belfast, Northern Ireland G&L Scientific

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G&L Scientific is a leading consultancy specializing in Regulatory Affairs and Quality Assurance. Our mission is to provide expert guidance that empowers our clients to navigate complex regulatory environments effectively. We are seeking a dedicated Regulatory Affairs Executive to join our team in Belfast. In this role, you will play a crucial part in ensuring compliance with regulatory standards, contributing significantly to our mission of delivering high-quality consultancy services. We are looking for someone who is enthusiastic and willing to develop the skills and knowledge required of a Regulatory Affairs professional in areas such as the drug development process, regulatory affairs, submissions management, publishing and/or other regulatory operations activity and requires a quality approach to documentation and an eye for detail. Responsibilities Keeping up to date with national and international regulatory legislation, guidelines, and customer practices Sharing of knowledge such as supporting the generation of training materials and regulatory intelligence Researching and authoring thought leadership content, to help build knowledge and understanding in a regulatory discipline. Support on high output regulatory project(s), which may involve preparation of high quality CMC regulatory documents using varied information sources and Regulatory Information Management (RIM) ensuring compliance in customers data.( Liaising closely with other stakeholders to ensure accuracy and completion of tasks to strict timelines. Working to agreed deadlines and maintaining records to reflect project status Responsible for highlighting potential delaying factors promptly to line management and sharing knowledge of regulatory documentation and procedures with others to assist in problem solving. Proactively pursuing process improvement and sharing of best practice Required Skills Science related degree e.g Biological Sciences, Biomedical Science.(RO5) Desirable: Previous experience in a Regulatory Affairs role.(RO6) Strong written and oral communication and networking skills Demonstrate ability to focus and work with attention to detail Demonstrate ability to retain critical information Demonstrate team working and effective time management skills Be a dynamic and highly motivated individual Establish strong relationships and liaise effectively with all applicable stakeholders. Be proficient in the use of IT packages such as Word and excel. Demonstrate problem solving skills If you are passionate about regulatory affairs and want to make a difference in the industry, we invite you to apply and join our dynamic team!
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Regulatory Affairs Officer

London, London SUN PHARMA

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Overall Job Purpose: The Regulatory Affairs (RA) Officer is primarily responsible for ensuring the appropriate licensing, marketing and legal compliance of Sun Pharma’s pharmaceutical and medical products in order to control the safety and efficacy of these products. The RA Officer combines scientific, legal and business knowledge to ensure Sun Pharma’s products meet the required legislation. He/she is responsible for the approval and registration of Sun Pharma’s products in UK market. Responsibilities: Is responsible for liaising with internal and external partners to receive the necessary documents in a timely manner, e.g. internally with R&D, RA and art work departments, externally with translations services and consultants for e.g. Package Leaflet User test reports. Is responsible for the preparation of SmPC, labelling and PILs texts according to the Quality Review of Documents (QRD) format. Is responsible for text verification of the product information documents. Is responsible for proof reading of art work of packaging materials. Ensure dossier technical content is optimal and aligned with UK Regulatory data requirements for new UK Marketing Authorisation Applications Maintains the life cycle management of the dossiers or the approved marketing authorizations as required by submitting variations/notifications/PSURs and renewals. Liaises with regulatory colleagues in the different country offices, corporate groups and competent authorities (MHRA) and third parties on regulatory issues. Works closely together with internal customers such as Research & Development, Artwork, Pharmacovigilance, Quality Assurance, Logistics, Finance, Business Development, Sales. Maintains RA archives (electronically). Keeps the Regulatory Information correct and accessible for other stakeholders. Being able to work with the required IT standards, like eCTD, XEVMPD Being able to work with the corporate IT systems like AMS, Trackwise, eDMS, eLMS, OneHR Determines and writes standard operating procedures. Qualifications: Bachelor or Master Degree (preferably in Life Sciences, Languages or Law) 2-5 years of experience in pharma Rounded knowledge of the UK and EU Regulatory Framework (directives, regulations, guidelines) Some understanding of the drug development process Able to comply with company standard operating procedures Good verbal and written communication skills in English Good IT skills including familiarity with Microsoft Office packages and specific packages/portals such as eCTD software, XEVMPD software, TVT, CESP, EMA gateway, MHRA and CBG portal. Excellent attention to detail Good time management skills Good organization and project management skills Good interpersonal and team working skills Presentation skills and experience of delivering training
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