530 Regulatory Affairs Specialists jobs in the United Kingdom

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!

Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
MISSION:
The Regulatory Affairs Specialist supports the regulatory vision and leadership of the Regulatory Team. They execute these responsibilities by utilizing experience, knowledge of regulatory landscape, passion and creativity to provide patient-centric and compliant regulatory expertise in line with AbbVie's vision. They support the best interests of patients, the Affiliate and AbbVie within the country with regard to interactions with the regulatory agency and other regulatory authorities. Within AbbVie they represent the department and affiliate to the wider organization throughout the product lifecycle. They contribute to the department's overall success by executing tactics and meeting objectives in line with business goals and culture.
Overall responsibilities (together with manager's oversight)
+ Supports the business of the company including involvement in planning for product launches, acquisitions and divestitures
+ Lifecycle management of applicable products and management of Clinical Trial activities with the MHRA
+ Work with Area Regulatory team to help advocate for the affiliate's strategy, objectives and timelines
+ Works with the regulatory department and collaborates other stakeholders, as appropriate, to ensure compliance with the company's policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of AbbVie
+ Authors SOPs, workflows and guides relevant to regulatory processes as required.
Main Accountabilities
+ Gain regulatory authority approval for new clinical trials and amendments to such trials undertaken by AbbVie Ltd in the UK
+ Gain marketing authorisations for new pharmaceutical products in the UK
+ Maintain marketing authorisations as required.
+ Liaise with European Regulatory Affairs and Corporate groups on regulatory issues.
+ Liaise with external regulatory authorities as required.
+ Draft of packaging texts, SmPCs, PILs and Prescribing Information.
+ Submit and obtain approval for Paediatric Investigation Plans (PIP)
+ Maintain awareness of current and new legislation/guidance and ensure that work is in compliance with the statutory requirements.
Qualifications
Required Education / Knowledge / Experience
+ Life Sciences Degree (e.g. Pharmacy) or equivalent experience preferred
+ Experience of working in a regulatory environment
+ Good communication skills, both verbal and written
+ The ability to thrive in a changing environment and to re-prioritise workload to meet business needs
+ Good project management skills desirable
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

**Regulatory Affairs Associate**
Are you a detail-oriented professional with a strong background in regulatory affairs, and pharmacovigilance? Are you looking to make a real impact in a dynamic, fast-paced pharmaceutical environment?
We're seeking a Regulatory Affairs Associate to support our Regulatory Compliance Manager (RCM) in ensuring that our operations stay at the forefront of regulatory excellence and patient safety while also helping us drive forward best practices in compliance, product information, and pharmacovigilance.
This is a full-time role of 37.5 hours, working Monday to Friday, 9am - 5pm. This is a hybrid role, our head office based in Huthwaite, Nottinghamshire.
**What does the role involve?**
**You will:**
+ **Lead local pharmacovigilance (PV)** activities, ensuring systems, reporting, and processes meet MHRA and GVP standards
+ **Support regulatory submissions** (e.g. licence applications, product updates) and keep product information up to date
+ **Review promotional and non-promotional materials** to ensure they comply with ABPI/IPHA codes
+ **Work closely with Marketing and internal teams** to provide clear, compliant advice and guidance
+ **Deliver training** on ABPI codes and PV requirements, and monitor compliance performance
**About You, you will:**
+ A degree in a life science discipline (e.g., Pharmacy, Pharmacology, Chemistry, Biology, Nursing)
+ Experience reviewing promotional materials under the ABPI Code
+ Knowledge of GVP, MDR, Human Medicines Regulation, and medical device vigilance
+ Excellent written and verbal communication skills
+ A proactive, adaptable mindset with the ability to prioritise in a fast-changing environment
+ Ideally have experience in regulatory submissions and medical device complaint handling (training can be provided)
**What can we offer you?**
Here at Fresenius Medical Care, we value the contribution of our people and ensure that we offer industry-leading rewards and progression.
We offer a competitive salary alongside a wealth of other fantastic benefits listed below:
+ Company Pension Scheme
+ Life Assurance
+ 33 Days Holiday (inclusive of 8 days bank holiday) increasing with service
+ Annual leave purchase scheme (with 12 months service)
+ Company paid health cash plan
+ Long Service Vouchers
+ Cycle to Work Scheme
+ bhsf RISE - our Health and Wellbeing hub 24/7 access to GP's and Counsellors
+ Blue Light card - providing thousands of amazing discounts online and on the high street
**Who is Fresenius Medical Care?**
We are the **leading provider of dialysis services** to the NHS, operating **52 partnership dialysis units** that together provide regular dialysis treatment to over **3,800 NHS patients in the UK** . We are part of a global company treating over **344,000 patients worldwide** across **over 4,000 clinics** .
We also operate **44 production sites on all continents** to provide dialysis products such as dialysis machines, dialysers and related disposables. **1 in every 2 of all dialysis machines** used around the globe are manufactured by Fresenius Medical Care and we are the **3rd largest medical devices company in the world.**
**Regulatory Affairs Assistant posts will be subject to a Basic DBS Disclosure**
**Fresenius Medical Care is an equal opportunities employer**

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec's revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit search for better is changing the lives of our customers. It's changing the careers of our people too - creating new challenges and opportunities all the time. We're a business that never stands still. Join us on our journey to #ForeverCaring
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!**

Be part of something altogether life-changing!
Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity - so you can grow your career and expand your skills in the long term.
Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics. The Regulatory Affairs Specialist for Cytiva is responsible for supporting regulatory compliance of Medical Devices placed on the market in EMEA.
This position is part of Medical Regulatory Affairs located in Portsmouth, UK and will be on-site. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.
What you will do:
+ Compile all aspects of Technical Documentation for product certification under Regulation (EU) 2017/745 for Medical Devices.
+ Submit Technical Documentation to Notified Bodies for review and approval.
+ Support RA related QMS documentation, Complaints Assessment, Vigilance Reports and Change Controls.
+ Support medical device Regulatory Intelligence process and customer requests.
+ Provide support as required for UK Responsible Person with regard to the requirements set out in the UK MDR 2002 relating to medical devices.
+ Participate in and support activities associated with the Medical Regulatory Affairs team objectives, as directed by line manager.
Who you are:
+ You have a Life Sciences degree or equivalent.
+ You have at least 2-3 years experience in a healthcare / life sciences industry in a regulatory or technical field.
+ Working knowledge of Medical Device regulations (EU MDR, MDCG guidelines, other EMEA), ISO 13485 and ISO 14971.
+ Experience with Quality Management System documentation.
+ Ability to communicate effectively across all departments and functions
+ Good attention to detail.
+ Have excellent English oral and written communication.
+ The ability to present technical, product and regulatory information clearly and concisely.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
+ Ability to travel required at 10% or less within the EMEA region.
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .

Be part of something altogether life-changing!
Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity - so you can grow your career and expand your skills in the long term.
Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics. The Regulatory Affairs Specialist for Cytiva is responsible for supporting regulatory compliance of Medical Devices placed on the market in EMEA.
This position is part of Medical Regulatory Affairs located in Portsmouth, UK and will be on-site. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.
What you will do:
+ Compile all aspects of Technical Documentation for product certification under Regulation (EU) 2017/745 for Medical Devices.
+ Submit Technical Documentation to Notified Bodies for review and approval.
+ Support RA related QMS documentation, Complaints Assessment, Vigilance Reports and Change Controls.
+ Support medical device Regulatory Intelligence process and customer requests.
+ Provide support as required for UK Responsible Person with regard to the requirements set out in the UK MDR 2002 relating to medical devices.
+ Participate in and support activities associated with the Medical Regulatory Affairs team objectives, as directed by line manager.
Who you are:
+ You have a Life Sciences degree or equivalent.
+ You have at least 2-3 years experience in a healthcare / life sciences industry in a regulatory or technical field.
+ Working knowledge of Medical Device regulations (EU MDR, MDCG guidelines, other EMEA), ISO 13485 and ISO 14971.
+ Experience with Quality Management System documentation.
+ Ability to communicate effectively across all departments and functions
+ Good attention to detail.
+ Have excellent English oral and written communication.
+ The ability to present technical, product and regulatory information clearly and concisely.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
+ Ability to travel required at 10% or less within the EMEA region.
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .

Be part of something altogether life-changing!
Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity - so you can grow your career and expand your skills in the long term.
Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics. The Regulatory Affairs Specialist for Cytiva is responsible for supporting regulatory compliance of Medical Devices placed on the market in EMEA.
This position is part of Medical Regulatory Affairs located in Portsmouth, UK and will be on-site. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.
What you will do:
+ Compile all aspects of Technical Documentation for product certification under Regulation (EU) 2017/745 for Medical Devices.
+ Submit Technical Documentation to Notified Bodies for review and approval.
+ Support RA related QMS documentation, Complaints Assessment, Vigilance Reports and Change Controls.
+ Support medical device Regulatory Intelligence process and customer requests.
+ Provide support as required for UK Responsible Person with regard to the requirements set out in the UK MDR 2002 relating to medical devices.
+ Participate in and support activities associated with the Medical Regulatory Affairs team objectives, as directed by line manager.
Who you are:
+ You have a Life Sciences degree or equivalent.
+ You have at least 2-3 years experience in a healthcare / life sciences industry in a regulatory or technical field.
+ Working knowledge of Medical Device regulations (EU MDR, MDCG guidelines, other EMEA), ISO 13485 and ISO 14971.
+ Experience with Quality Management System documentation.
+ Ability to communicate effectively across all departments and functions
+ Good attention to detail.
+ Have excellent English oral and written communication.
+ The ability to present technical, product and regulatory information clearly and concisely.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
+ Ability to travel required at 10% or less within the EMEA region.
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .

Regulatory Affairs Specialist - Medical Devices, Hybrid, contract job Your new company Our client, a leading player in the medical device sector, is seeking a proactive and detail-oriented Regulatory Affairs Specialist to join their MBD Regulatory Affairs team. Microbiology Division of the Speciality Diagnostics GroupThis is a 5-month contract job. Your new role In this pivotal role, you'll support the full product lifecycle, ensuring regulatory compliance across global markets. You'll collaborate with cross-functional teams including Market Access, Commercial, Operations, R&D, QA, and Product Management, as well as engage with regulatory agencies and regional teams.Key Responsibilities: Maintain and review regulatory submissions, technical files, and product labelling. Assess operational change requests and their impact on licences. Respond to customer and commercial enquiries on product classification and regulatory status. Support pre- and post-market licence applications across global territories. Assist in audit readiness and regulatory planning. Stay up to date with global IVD regulations and market intelligence. What you'll need to succeed What We're Looking For: Strong communication skills and attention to detail. Proven experience in regulatory affairs within medical devices or IVD. Ability to manage multiple priorities in a fast-paced, matrixed environment. Proficiency in SAP, MasterControl, and Microsoft Office Suite. A self-starter with a collaborative mindset and a passion for continuous improvement. What you'll get in return Flexible working options available. What you need to do now For more information on this or any other Regulatory Affairs contract jobs, please apply for this advert.