80 Regulatory Affairs Specialist jobs in the United Kingdom
Regulatory Affairs Specialist
Posted today
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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!
Regulatory Affairs Specialist
Posted 3 days ago
Job Viewed
Job Description
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!
Regulatory Affairs Specialist
Posted 9 days 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 Specialist
Posted 7 days ago
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Sinclair is Hiring! Join Our Team as a Regulatory Affairs Specialist
Regulatory Affairs Specialist
Posted 7 days ago
Job Viewed
Job Description
Our clients are seeking a proactive and detail-oriented Regulatory Affairs Specialist to join their growing team. You will play a critical role in ensuring that our chemical products meet all applicable regulatory requirements across the cosmetics, pharmaceutical, and home care sectors. This position requires an understanding of global chemical regulations and experience coordinating with cross-functional teams to support product compliance from development to market launch.
Key Responsibilities:
- Ensure compliance of raw materials and finished products with relevant chemical regulations (e.g., REACH, CLP, FDA, EU Cosmetics Regulation, EPA, etc.).
- Prepare, review, and maintain regulatory documentation including safety data sheets (SDS), product dossiers, technical files, and product registrations.
- Serve as the regulatory point of contact for internal teams (R&D, Marketing, QA, Sales) and external regulatory bodies or clients.
- Monitor changes in global regulations and provide impact assessments and guidance to the business.
- Coordinate regulatory submissions for product approvals, renewals, and amendments in various markets.
- Manage ingredient listings and restrictions based on applicable legislations (e.g., INCI for cosmetics, pharmacopeias for pharmaceuticals).
- Support product labeling and claims compliance across all relevant product lines.
- Participate in audits and inspections, ensuring readiness and full documentation availability.
- Contribute to continuous improvement in regulatory processes and tools.
Qualifications & Skills:
- Bachelor’s degree in Chemistry, Regulatory Affairs, Pharmaceutical Sciences, or a related field.
- 2–5 years of regulatory experience in the chemical industry, preferably with exposure to cosmetics, pharmaceuticals, and/or home care products.
- Solid knowledge of global chemical and product regulations (e.g., EU, US, APAC).
- Experience with regulatory databases and tools (e.g., IUCLID, ECHA REACH-IT, CosIng).
- Strong organizational, analytical, and communication skills.
- Detail-oriented with the ability to manage multiple priorities under tight deadlines.
Regulatory Affairs Specialist
Posted 4 days ago
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Job Description
Regulatory Specialist for a leading multinational coatings company based in the North Lancashire area.
Company: Leading coatings manufacturer, which owns some of the largest and most recognisable brands in the UK and the rest of the world. Profits from the organisation go towards education funds and other worthwhile causes.
Hours of work: Flexible working hours - 37.5 hours per week, starting between.
WHJS1_UKTJ
Regulatory Affairs Compliance Specialist
Posted 5 days ago
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Job Description
Title: Regulatory Affairs Compliance Specialist
Location: UK hybrid or Remote in UK
Position: Permanent Full-time
About Petlab Co
PetLab Co. is the world’s fastest-growing pet supplement business. Launching in 2018, we successfully achieved a 9-figure revenue in 2022 without any external funding. We have a loyal community of loving pet parents and over 1.5 million happy dogs whose lives have been positively impacted by our innovative products. Our team is vibrant, fast-moving, and customer-driven where high-performers are valued and rewarded. And it is the ideal place for an ambitious, hardworking, animal lover who wants to progress their career rapidly.
A Day In The Life…
Our Compliance Director is looking for a hard-working, highly driven, and passionate Regulatory Affairs Compliance Specialist to join the team. This role would be suitable for someone who is very meticulous with excellent time management skills and enjoys working both autonomously and as part of a growing team. We are growing incredibly fast and that’s why we need an extra pair of hands-on deck to provide a great service to the business and to our customers.
Marketing plays a pivotal part in our business and a primary function of this role would be to review and approve marketing content in accord with regulatory requirements in a timely fashion, therefore making it crucial to our growth! We move and think fast so it’s important that you can thrive in a fast-paced environment and are happy to roll up your sleeves to do whatever it takes to support the team in every way possible. If that sounds exciting - we would love you to join our pack!
Your day to day will look a little bit like this…
- Review marketing content to ensure relevant compliance requirements are met
- Support product registrations in various countries/states
- Support the planning and execution of product trials and regulatory inspections
- Keep up to date with changes in regulatory legislation and guidelines
- Assist with implementing requirements for labelling, storage and packaging
- Assist with regulatory review of product labels and other claims
- Liaise with regulatory authorities
- Assist with the internal complaints process; reporting and advising accordingly
- Support the Quality team with implementing the HACCP policy and other Quality requirements
- Review claims substantiation
- Build and maintain a knowledge database - appropriately storing, keeping track and disseminating information within the team
- Ensure maintenance of regulatory databases and trackers
- Assist with upcoming expansions into new markets and product categories
- Study key scientific and legal regulatory documents relating to new and existing products
- Cooperate with the New Product Development team and the Quality team in order to assist with timely product launches
- Support with the claim’s substantiation process
- Research potential risks in relation to both new and existing products; reporting and advising accordingly
Requirements
What You Need…
- 2 -3 years proven experience in a Regulatory/ Compliance environment – (Food, Pharma, Animal feed or supplement sector would be highly advantageous)
- Previous experience working with regulatory agencies advantageous
- Knowledge of Product Compliance (Labels, Creatives, Social media, blogs)
- Strong communication and organisational skills
- Drive to make things happen, using initiative and logic - a true 'self-starter'
- Demonstrate strong attention to detail, collaborative, consultative, with excellent problem-solving and communication skills
- Team player with the ability to work autonomously
- Strong knowledge of Microsoft Office and a willingness to learn additional software on the job
- Ability to Multitask: ability to switch tasks smoothly, managing stress levels effectively in fast-paced situations.
- Great Organisation skills: planning ahead, always well prepared for meetings, while seeking to maximise time and productivity
- Accountability: committed to follow-through, owning their work, and taking corrective action where necessary.
- Adaptability: maintains flexibility in response to changing priorities with a positive attitude.
- Resourcefulness: when presented with a challenge proactively finds solutions to present to the team, demonstrating a proactive approach is extremely important.
- Strong time management: understanding hard and soft deadlines, timely communication, and respecting others' schedules.
- Team player: working well within a team environment, while making sure the team is effective across the board.
Benefits
- Private Health Care through Vitality
- Generous Annual Leave - 28 days + public and bank holidays
- – Employee Assistance Programme
- Royal London Pension Scheme – We offer a workplace pension scheme with one of the UK’s leading providers of group pensions. With an employer contribution of 5%!
- Enhanced Maternity / Paternity / Adoption Leave – because time with new family members is important!
- Nursery Salary Sacrifice Scheme
- Generous Learning and development budget – We always want you to keep learning.
- Puppy Therapy – working in partnership with Paws in Work to provide a boost of oxytocin twice a year.
- Generous Learning and development budget – We always want you to keep learning.
- Free breakfast, fruits and snacks – refuel and revitalise with free munchies in the office.
- Working Environment – dogs are welcome!
- Life Assurance – In the event of your death, while employed by us, your chosen beneficiaries will be provided with a tax-free lump sum equivalent of four times your basic salary.
- Discount Vouchers & Gym Memberships – get discounts at a whole range of retailers and gym memberships through our provider, Sodexo.
- Electric Vehicle Scheme – Employees sacrifice salary in return for a new electric car, typically saving 30-40% of costs through income and tax and national insurance.
- Give Back Day – An extra day off in the year to volunteer plus a £50 contribution to your chosen charity.
- Health Cash Benefit – We offer the bronze package with enables you to claim a certain amount of cashback when you pay for something that is health related, i.e dental
Petlab Co is an equal opportunity employer that is committed to diversity and inclusion. We encourage all applications irrespective of gender, race, sexual orientation, religion, age, nationality, marital status, and disability. We believe that diversity is at the heart of innovation and we welcome passionate candidates from all backgrounds. Come join the family and see for yourself!
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Principal Regulatory Affairs Specialist
Posted 9 days ago
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**Abbott Diabetes Care**
**Witney, Oxfordshire**
**Competitive Salary + Excellent Benefits**
Abbott Diabetes Care designs, develops and manufactures leading-edge glucose monitoring systems and test strips for use in both home and hospital settings. Our product portfolio includes Freestyle Libre, a recently launched system that is revolutionising how people with diabetes around the world monitor their glucose levels. We are passionate about doing work that improves the quality of people's lives.
We currently have an opportunity for a Principal Regulatory Affairs Specialist to join our team, based in Oxfordshire, supporting the significant manufacturing capacity expansion underway at the Witney site plus other Operational and R&D projects.
**Primary Job Function**
This position is responsible for planning, creating and implementing solutions for regulatory registration and release of products for distribution into specific geographies.
**Core Job Responsibilities**
+ Executes and Ensures Product Registration,
+ Release Authorization and Release for Distribution.
+ Oversee processes and team involved with obtaining and maintaining product registration, release authorization and release of product to specified geographies.
+ Coordinates with cross functional teams including but not limited to: US Regulatory, International Regulatory, Marketing / PLC, Supply Planning, Customer Service, Quality, R&D, Operations, etc. to ensure all internal and external requirements are met prior to product release.
+ Identify risk areas and escalate issues as appropriate.
+ Manage multiple programs with minimal oversight.
+ Product Release Process Ownership
+ Develops processes and tools to support controlled product release. Responsible for development, maintenance and compliance with applicable Corporate and Divisional Policies and procedures.
+ Product Registration, Release Authorization and Release Planning
+ Provide Regulatory input to product lifecycle planning
+ Provide Regulatory input to strategy based upon regulatory changes
+ Identify and react to emerging issues
+ Analyse product-associated problems and develop proposals for solutions Acts as a liaison with other departments, e.g., Quality, R&D, Legal, Operations, Marketing and Clinical Affairs, for major initiatives.
+ Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback.
+ Maintains a safe and professional work environment.
+ Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
+ Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
+ Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
**Position Accountability / Scope**
+ Ensure timely registration of all current and new ADC products with the appropriate regulatory authorities.
+ Plan and manage the non-project-related workload of Regulatory team members to maintain efficiency and alignment with departmental goals.
+ Oversee the accurate and efficient management of regulatory systems to ensure traceability and accessibility of records for future reference.
+ Supervise Regulatory team members in developing strategies for both project and non-project-related workstreams.
+ Support the line manager in shaping and executing departmental-level Regulatory strategies.
**Minimum** **Education**
+ Educated to degree level or equivalent preferably in a Scientific discipline e.g., Chemistry, life Sciences, Biology.
**Minimum** **Experience/Training Required**
+ The ideal candidate will hold a degree (or equivalent qualification), preferably in a Science or Engineering discipline, and will have prior experience in Regulatory Affairs within the Medical Device or In Vitro Diagnostics (IVD) sector.
We are particularly looking for individuals with:
+ A solid understanding of the EU Medical Device Regulation (MDR - Regulation (EU) 2017/745) and/or the In Vitro Diagnostic Medical Device Regulation (IVDR - Regulation (EU) 2017/746)
+ Experience working within an ISO 13485-certified Quality Management System
+ Proven international registration experience, ideally with a focus on Asia Pacific markets
+ Proficiency in Chinese is considered a strong advantage
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
Regulatory Affairs Specialist -Med Devices
Posted today
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Role - QA/RA Senior Specialist
Location - London
Hours 40 hours Monday to Friday
Salary £50,000 to £60,000
Overview
We are seeking a highly skilled QA/RA Senior Specialist to join our clients team. To succeed in this role, you will bring extensive experience in Quality Assurance and Regulatory Affairs within the Medical Device industry , with a strong command of ISO 13485 , regulatory compliance , and post-market requirements.
You will play a key role in maintaining and improving our Quality Management System (QMS), guiding internal and external audits, and ensuring our products meet applicable regulatory standards throughout their lifecycle.
Key Responsibilities
- Develop, implement, and maintain Quality and Regulatory processes in line with applicable regulations and standards (e.g., ISO 13485, MDR). li>Drive continuous improvement initiatives within the QMS.
- Collaborate cross-functionally and with the external subcontractors to ensure ongoing regulatory compliance.
- Provide QA/RA support during changes and product lifecycle management.
- Lead risk management activities and oversee post-market surveillance processes.
- Conduct thorough root cause investigations and manage Corrective and Preventive Actions (CAPA).
- Coordinate the preparation and maintenance of technical and regulatory documentation.
- Develop, maintain, and execute internal and external audit plans to ensure audit readiness and compliance.
- Author, review, and update QMS policies, procedures, and work instructions.
- Monitor and implement regulatory updates, ensuring company compliance with evolving standards.
- Ensure SOPs are appropriately established, implemented, and followed across all functions.
- Deliver internal training to enhance regulatory and quality awareness throughout the organization.
Required Experience, Skills & Qualifications
- Proven Quality Assurance experience in the Medical Device sector .
- Bachelor's degree (or higher) in a scientific or engineering discipline.
- In-depth knowledge of ISO 13485 , EU MDR , and global regulatory requirements. < i>Demonstrated experience managing internal and external audits, including interaction with regulatory bodies and notified bodies.
- Strong understanding of QMS development, maintenance, and continuous improvement.
- Skilled in compiling and maintaining technical documentation
- Strong analytical, organizational, and communication skills.
- Ability to work independently and collaboratively in a cross-functional environment.
The Ideal Candidate
You are a proactive, detail-oriented QA/RA professional with a passion for maintaining the highest standards of compliance and quality in medical device development. You’re a natural collaborator with excellent communication and problem-solving skills, ready to contribute to continuous improvement across both regulatory and quality initiatives.
Regulatory Affairs Specialist -Med Devices
Posted 3 days ago
Job Viewed
Job Description
Role - QA/RA Senior Specialist
Location - London
Hours 40 hours Monday to Friday
Salary £50,000 to £60,000
Overview
We are seeking a highly skilled QA/RA Senior Specialist to join our clients team. To succeed in this role, you will bring extensive experience in Quality Assurance and Regulatory Affairs within the Medical Device industry , with a strong command of ISO 13485 , regulatory compliance , and post-market requirements.
You will play a key role in maintaining and improving our Quality Management System (QMS), guiding internal and external audits, and ensuring our products meet applicable regulatory standards throughout their lifecycle.
Key Responsibilities
- Develop, implement, and maintain Quality and Regulatory processes in line with applicable regulations and standards (e.g., ISO 13485, MDR). li>Drive continuous improvement initiatives within the QMS.
- Collaborate cross-functionally and with the external subcontractors to ensure ongoing regulatory compliance.
- Provide QA/RA support during changes and product lifecycle management.
- Lead risk management activities and oversee post-market surveillance processes.
- Conduct thorough root cause investigations and manage Corrective and Preventive Actions (CAPA).
- Coordinate the preparation and maintenance of technical and regulatory documentation.
- Develop, maintain, and execute internal and external audit plans to ensure audit readiness and compliance.
- Author, review, and update QMS policies, procedures, and work instructions.
- Monitor and implement regulatory updates, ensuring company compliance with evolving standards.
- Ensure SOPs are appropriately established, implemented, and followed across all functions.
- Deliver internal training to enhance regulatory and quality awareness throughout the organization.
Required Experience, Skills & Qualifications
- Proven Quality Assurance experience in the Medical Device sector .
- Bachelor's degree (or higher) in a scientific or engineering discipline.
- In-depth knowledge of ISO 13485 , EU MDR , and global regulatory requirements. < i>Demonstrated experience managing internal and external audits, including interaction with regulatory bodies and notified bodies.
- Strong understanding of QMS development, maintenance, and continuous improvement.
- Skilled in compiling and maintaining technical documentation
- Strong analytical, organizational, and communication skills.
- Ability to work independently and collaboratively in a cross-functional environment.
The Ideal Candidate
You are a proactive, detail-oriented QA/RA professional with a passion for maintaining the highest standards of compliance and quality in medical device development. You’re a natural collaborator with excellent communication and problem-solving skills, ready to contribute to continuous improvement across both regulatory and quality initiatives.