118 Regulatory Affairs Specialist jobs in the United Kingdom
Regulatory Affairs Specialist
Posted 1 day ago
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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 1 day 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 1 day ago
Job Viewed
Job Description
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.
Regulatory Affairs Specialist
Posted 1 day ago
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Job Description
Walker Cole is looking for a Regulatory Affairs Specialist to join a leading UK Pharmaceutical Manufacturer based in Hertfordshire. This present the chance to be a part of a supportive community focused on growth and development. This is an exciting opportunity for exposure and to build your career.
As a Regulatory Affairs Specialist, you will:
- Prepare and submit regulatory documents (MAAs, variations) to health authorities for product approvals and lifecycle maintenance.
- Monitor and interpret regulatory changes to ensure company-wide compliance.
- Develop and implement regulatory strategies in collaboration with cross-functional teams.
- Review and approve labelling and packaging to meet regulatory standards.
- Manage post-marketing activities, including variations, updates, and pharmacovigilance support.
- Apply CMC knowledge to support stability studies, shelf-life claims, and regulatory documentation.
- Act as the main point of contact with regulatory agencies, handling queries and submissions.
- Collaborate with QA, QC, and Manufacturing teams to maintain compliance across the product lifecycle.
- Maintain up-to-date regulatory intelligence to guide strategic decision-making.
A Regulatory Affairs Specialist will need:
- Degree in Pharmacy, Life Sciences, Regulatory Affairs, or related field (advanced degree preferred)
- Strong knowledge of MHRA, EMA, and ICH regulatory requirements
- Excellent attention to detail with strong written and verbal communication skills
- Skilled in managing multiple projects and working in cross-functional teams
- Proficient in regulatory systems such as eCTD Manager is mandatory
Regulatory Specialist // eCTD // ICH // MHRA // EMA // MAA // Life Cycle Maintenance // Labelling // CMC
Regulatory Affairs Specialist
Posted 3 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 3 days ago
Job Viewed
Job Description
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
Posted 3 days ago
Job Viewed
Job Description
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 .
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Regulatory Affairs Specialist
Posted 3 days ago
Job Viewed
Job Description
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
Posted today
Job Viewed
Job Description
Key Responsibilities:
- Prepare, review, and submit regulatory documentation for product registrations, variations, and renewals to health authorities worldwide.
- Ensure compliance with all applicable national and international pharmaceutical regulations (e.g., EMA, FDA, MHRA).
- Liaise with regulatory agencies on behalf of the company, responding to queries and managing communications.
- Monitor and interpret new and updated regulatory guidelines and assess their impact on the company's products and processes.
- Develop and maintain regulatory strategies for new product development and lifecycle management.
- Review and approve marketing materials, labelling, and packaging to ensure regulatory compliance.
- Manage post-approval regulatory activities, including annual reports and safety updates.
- Collaborate with R&D, Quality Assurance, Medical Affairs, and Commercial departments to provide regulatory guidance and support.
- Maintain regulatory databases and filing systems.
- Contribute to the development and implementation of internal regulatory SOPs.
- Support due diligence activities for potential partnerships or acquisitions.
- Provide training on regulatory requirements to relevant personnel.
- Participate in cross-functional project teams to ensure regulatory considerations are integrated into product development.
Qualifications:
- Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related discipline. Master's degree preferred.
- Minimum of 3 years of experience in regulatory affairs within the pharmaceutical or biotech industry.
- Comprehensive knowledge of global pharmaceutical regulatory requirements and submission processes.
- Experience with preparing and submitting Common Technical Document (CTD) dossiers.
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication skills, with a keen eye for detail.
- Ability to manage multiple projects and deadlines effectively.
- Proficiency in regulatory information management systems and Microsoft Office Suite.
- Strong understanding of drug development processes.
This is an exceptional opportunity for a motivated Regulatory Affairs Specialist to contribute to a leading pharmaceutical company, ensuring their innovative products reach patients safely and effectively in a key Thames Valley location.
Regulatory Affairs Specialist
Posted 18 days ago
Job Viewed
Job Description
ABOUT ORGANOX:
OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company’s first product, the OrganOx metra ® normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 5,000 liver transplant operations globally.
Position Summary
The Regulatory Affairs Specialist is responsible for performing regulatory administration and support activities for OrganOx Limited.
Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally exhaustive.
This is an office based role in Oxford with flexibility.
Major Responsibilities
Under direction from the Regulatory Affairs Manager, the Regulatory Affairs Specialist will be responsible for:
- Perform and/or coordinate regulatory documentation updates as requested by the Regulatory Affairs Manager to support the relevant department(s) in fulfilling regulatory requirements
- Under the instruction of the Regulatory Affairs Manager, perform administration and compilation of documentation needed for regulatory submissions
- Working with wider team members to gather required information for change submissions to the Notified Body
- Assist with submission of change requests to the Notified Body (NB), logging NB responses or approvals and assisting with any requests for further information.
- Assist the Regulatory Affairs Manager with maintenance and creation of product registrations and certifications
- Support the Regulatory Affairs Manager with data gathering and analysis for trend reporting into Post Market Surveillance activities
- Work with the Global Labelling and Compliance Manager and Regulatory Affairs Manager to maintain regulatory information within OrganOx’s Regulatory Information Management Software, RIMSYS
- Assist with training for new and existing employees on the RIMSYS Regulatory Information Management Platform
- Assist the Global Labelling and Compliance Manager to maintain Technical File documentation
- Assist the Global Labelling and Compliance Manager with maintenance and control of product labelling
- Assist during notified body audits
- Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies
Requirements
Skills & Experience
- Demonstrable experience in regulatory affairs or quality within the medical device industry
- Experience working within ISO 13485:2016 quality management system
- The ability to work within a fast paced, changing environment and comfortable dealing with ambiguity
- Experience of administration of documentation for regulatory submissions (Desirable)
- Experience in maintenance of medical device registrations EU/UK (Desirable)
- High level of attention to detail
- Strong scientific writing skills
- Proficient in Microsoft Word and Excel
- Excellent organization skills
Qualifications
- A bachelor’s degree is preferred but not essential
Benefits
At OrganOx, we value innovation, evidence, integrity, teamwork, respect, and passion. We offer competitive compensation and comprehensive benefits, including healthcare and retirement plans. We support work-life balance and provide opportunities for ongoing professional development.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex, sexual orientation race, or any other characteristics protected by law.