57 Legislation jobs in the United Kingdom

Regulatory Affairs Manager

London, London £24 Hourly Gi Group

Posted 1 day ago

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Job Description

temporary

Regulatory Affairs Manager / Remote / 24.43 per hour PAYE

We are seeking an experienced Regulatory Affairs Manager to lead and support complex clinical trial application projects across Europe and beyond. This fully remote contractor role offers the opportunity to work on strategic regulatory initiatives, collaborate with global teams, and guide clients through the evolving EU Clinical Trials Regulation (EUCTR) landscape.

About the Role

This is a strategic, client-facing position focused on pre-approval clinical trial applications , particularly under the EUCTR framework. You will oversee regulatory submissions via the CTIS portal , manage cross-functional collaboration, and provide expert guidance on documentation, timelines, and regulatory strategy.

Key Responsibilities

  • Lead EUCTR submissions, including preparation of core packages for Part 1 and coordination with local teams for Part 2 .
  • Ensure familiarity with redactions and the regulatory distinctions between Part 1 and Part 2.
  • Develop and execute regulatory submission strategies , including review of CMC and IMPD data.
  • Provide strategic oversight of clinical trial applications, not limited to operational submission tasks.
  • Collaborate with country teams on ethics submissions and post-submission maintenance (e.g., notifications, substantial amendments).
  • Engage directly with clients to guide documentation requirements, set timelines, and communicate regulatory expectations.
  • Review and manage project budgets, ensuring scope alignment and revenue recognition.
  • Support global regulatory initiatives and contribute to SOP development and review.
  • Mentor junior colleagues and contribute to internal training and development.

What We're Looking For

  • Minimum 8 years of relevant regulatory experience in life sciences.
  • Proven expertise in EUCTR , CTIS , and clinical trial applications .
  • Strong technical writing skills, particularly in compiling IMPD and CMC data.
  • Strategic mindset with experience in regulatory planning and client-facing communication.
  • Ability to manage multiple projects, with assignments varying based on project size and scope.
  • Experience in biotech, cell and gene therapy, or IVD is beneficial but not required.

Bonus Skills

  • Experience with regulatory submissions in US, Canada, Latin America, or sub-Saharan Africa .
  • Familiarity with regulatory portals such as Swissmedic and ARIS for UK submissions.
  • Understanding of pharmacovigilance activities relevant to marketing authorisation transfers.

This is a 6 month Temporary contract with the potential to extend.





__PRESENT__PRESENT

Should you require any support or assistance, please contact your local Gi Group office.

Gi Group Holdings Recruitment Limited are proud founding members of Menopause in business, pledge members for Neurodiversity in business, Disability committed members, Silver status pledge members for the Armed Forces Covenant, and Bronze trail blazers for Racial Equality matters.

Gi Group of companies includes Gi Group Holdings Recruitment Ltd, Gi Recruitment Ltd, Draefern Ltd, Excel Resourcing (Recruitment Consultants) Ltd, Gi Recruitment Ltd, INTOO (UK) Ltd, Marks Sattin (UK) Ltd, TACK TMI UK Ltd, TACK International Ltd, Grafton Professional Staffing Ltd, Encore Personnel Services Ltd, Gi Group Staffing Solutions Ltd and Gi Group Ireland Ltd. Gi Group Staffing Solutions Ltd are acting as an Employment Business in relation to this role.

We are committed to protecting the privacy of all our candidates and clients. If you choose to apply, your information will be processed in accordance with the Gi Group Privacy Statement. To view a copy and to help you understand how we collect, use and process your personal data please visit the Privacy page on our Gi Group website.

This advertiser has chosen not to accept applicants from your region.

Regulatory Affairs Officer

Cheshire, North West Smart4Sciences

Posted 2 days ago

Job Viewed

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Job Description

permanent

Regulatory Affairs Officer

I am working with a pharmaceutical/ Medical Device manufacturing site based in Deeside specialising in challenge meals, this is a good opportunity for an experienced Regulatory Affairs Officer to develop their career with an expanding company.

Key responsibilities for the Regulatory Affairs Officer

  • Preparation and maintenance of regulatory documents for the product portfolio
  • Stay up to date with market changes, trends, and regulations
  • Support with client communication for the regulatory activities, such as submissions.
  • Ensure regulatory documentation is compliant with internal and external regulations.
  • Work closely with the internal SLT team and ensure that updated are provided for the regulatory changes and trends.

Requirements for the Regulatory Affairs Officer

  • Bachelor's degree in a scientific discipline or equivalent.
  • Good understanding cGMP.
  • 3 years' experience working within pharmaceutical Regulatory Affairs.
  • Understanding of MHRA and FDA Regulations.

Benefits for the Regulatory Affairs Officer

  • Good career progression opportunities with the potential of becoming the Regulatory Affairs Manager
  • Generous holiday allowance
  • Niche product proving a great career experience.
  • Free parking

To apply for the Regulatory Affairs Officer or here more information, please contact Liam Shannon at Smart4Sciences on (phone number removed) or email me at

This advertiser has chosen not to accept applicants from your region.

Regulatory Affairs Manager

Lancashire, North West £65000 - £70000 Annually E3 Recruitment

Posted 4 days ago

Job Viewed

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Job Description

permanent

Are you an experienced Regulatory Affairs Manager looking to make a impact in the chemical manufacturing industry? We are seeking a proactive and detail-oriented professional to lead the regulatory strategy and ensure full compliance across site operations.

As a Regulatory Affairs Manager , you will play a critical role in navigating complex regulatory environments, working cross-functionally with R&D, production, quality, and commercial teams to support product compliance and market access. Your expertise will directly influence the ability to innovate safely and responsibly.

Key Responsibilities of Regulatory Affairs Manager :

  • Serve as the primary Regulatory Affairs Manager for all chemical regulatory matters, including REACH, TSCA, SEPA and other global compliance frameworks.
  • Prepare, submit, and maintain product registration dossiers and regulatory filings.
  • To complete the REACH registration of the full product range within the time limits set by ECHA.
  • Work closely with the SHE Manager and operations to ensure that the manufacturing process, human health and environmental exposure meet the scope of the CSR for each registered product.
  • Maintain material safety data sheet for all products which conform to the legislative requirements of both the U.K. and the countries into which the products are sold.
  • Collaborate closely with internal stakeholders to integrate regulatory requirements into product development and manufacturing processes.
  • Represent the company with regulatory agencies and industry associations.
  • Interpret regulatory legislation as applied to chemical entities so that the company can achieve its registration requirements in full, on time and at the most efficient cost; Monitoring and interpreting regulatory changes, advising the business on potential impacts

Qualifications required from Regulatory Affairs Manager :

  • Bachelor's degree or higher in Chemistry, Chemical Engineering, Regulatory Affairs, or related field.
  • Minimum 3-5 years' experience in regulatory affairs within chemical manufacturing.
  • Working knowledge of international chemical regulations and compliance systems.
  • Strong communication and interpersonal skills-ability to work well with people across all levels of the organisation.

What We Value:

We're looking for someone who not only excels in as a Regulatory Affairs Manager but also thrives in a team-oriented environment and helps foster a positive, values-driven workplace.

This is a chance to join a company that values innovation, and strong relationships. If you're ready to bring your regulatory expertise to a team where culture matters, we'd love to hear from you.

Apply today to become our next Regulatory Affairs Manager and help shape the future of safe, sustainable chemical manufacturing.

This advertiser has chosen not to accept applicants from your region.

Regulatory Affairs Specialist

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

Posted 4 days ago

Job Viewed

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Job Description

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!

This advertiser has chosen not to accept applicants from your region.

Regulatory Affairs Manager

EC1 London, London Gi Group

Posted today

Job Viewed

Tap Again To Close

Job Description

temporary

Regulatory Affairs Manager / Remote / 24.43 per hour PAYE

We are seeking an experienced Regulatory Affairs Manager to lead and support complex clinical trial application projects across Europe and beyond. This fully remote contractor role offers the opportunity to work on strategic regulatory initiatives, collaborate with global teams, and guide clients through the evolving EU Clinical Trials Regulation (EUCTR) landscape.

About the Role

This is a strategic, client-facing position focused on pre-approval clinical trial applications , particularly under the EUCTR framework. You will oversee regulatory submissions via the CTIS portal , manage cross-functional collaboration, and provide expert guidance on documentation, timelines, and regulatory strategy.

Key Responsibilities

  • Lead EUCTR submissions, including preparation of core packages for Part 1 and coordination with local teams for Part 2 .
  • Ensure familiarity with redactions and the regulatory distinctions between Part 1 and Part 2.
  • Develop and execute regulatory submission strategies , including review of CMC and IMPD data.
  • Provide strategic oversight of clinical trial applications, not limited to operational submission tasks.
  • Collaborate with country teams on ethics submissions and post-submission maintenance (e.g., notifications, substantial amendments).
  • Engage directly with clients to guide documentation requirements, set timelines, and communicate regulatory expectations.
  • Review and manage project budgets, ensuring scope alignment and revenue recognition.
  • Support global regulatory initiatives and contribute to SOP development and review.
  • Mentor junior colleagues and contribute to internal training and development.

What We're Looking For

  • Minimum 8 years of relevant regulatory experience in life sciences.
  • Proven expertise in EUCTR , CTIS , and clinical trial applications .
  • Strong technical writing skills, particularly in compiling IMPD and CMC data.
  • Strategic mindset with experience in regulatory planning and client-facing communication.
  • Ability to manage multiple projects, with assignments varying based on project size and scope.
  • Experience in biotech, cell and gene therapy, or IVD is beneficial but not required.

Bonus Skills

  • Experience with regulatory submissions in US, Canada, Latin America, or sub-Saharan Africa .
  • Familiarity with regulatory portals such as Swissmedic and ARIS for UK submissions.
  • Understanding of pharmacovigilance activities relevant to marketing authorisation transfers.

This is a 6 month Temporary contract with the potential to extend.





__PRESENT__PRESENT

Should you require any support or assistance, please contact your local Gi Group office.

Gi Group Holdings Recruitment Limited are proud founding members of Menopause in business, pledge members for Neurodiversity in business, Disability committed members, Silver status pledge members for the Armed Forces Covenant, and Bronze trail blazers for Racial Equality matters.

Gi Group of companies includes Gi Group Holdings Recruitment Ltd, Gi Recruitment Ltd, Draefern Ltd, Excel Resourcing (Recruitment Consultants) Ltd, Gi Recruitment Ltd, INTOO (UK) Ltd, Marks Sattin (UK) Ltd, TACK TMI UK Ltd, TACK International Ltd, Grafton Professional Staffing Ltd, Encore Personnel Services Ltd, Gi Group Staffing Solutions Ltd and Gi Group Ireland Ltd. Gi Group Staffing Solutions Ltd are acting as an Employment Business in relation to this role.

We are committed to protecting the privacy of all our candidates and clients. If you choose to apply, your information will be processed in accordance with the Gi Group Privacy Statement. To view a copy and to help you understand how we collect, use and process your personal data please visit the Privacy page on our Gi Group website.

This advertiser has chosen not to accept applicants from your region.

Regulatory Affairs Officer

Smart4Sciences

Posted 2 days ago

Job Viewed

Tap Again To Close

Job Description

full time

Regulatory Affairs Officer

I am working with a pharmaceutical/ Medical Device manufacturing site based in Deeside specialising in challenge meals, this is a good opportunity for an experienced Regulatory Affairs Officer to develop their career with an expanding company.

Key responsibilities for the Regulatory Affairs Officer

  • Preparation and maintenance of regulatory documents for the product portfolio
  • Stay up to date with market changes, trends, and regulations
  • Support with client communication for the regulatory activities, such as submissions.
  • Ensure regulatory documentation is compliant with internal and external regulations.
  • Work closely with the internal SLT team and ensure that updated are provided for the regulatory changes and trends.

Requirements for the Regulatory Affairs Officer

  • Bachelor's degree in a scientific discipline or equivalent.
  • Good understanding cGMP.
  • 3 years' experience working within pharmaceutical Regulatory Affairs.
  • Understanding of MHRA and FDA Regulations.

Benefits for the Regulatory Affairs Officer

  • Good career progression opportunities with the potential of becoming the Regulatory Affairs Manager
  • Generous holiday allowance
  • Niche product proving a great career experience.
  • Free parking

To apply for the Regulatory Affairs Officer or here more information, please contact Liam Shannon at Smart4Sciences on (phone number removed) or email me at

This advertiser has chosen not to accept applicants from your region.

Regulatory Affairs Specialist

WD1 Watford, Eastern ARx Recruitment Services

Posted 7 days ago

Job Viewed

Tap Again To Close

Job Description

full time

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!

This advertiser has chosen not to accept applicants from your region.
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Regulatory Affairs Manager

BB5 Waterloo, North West E3 Recruitment

Posted 7 days ago

Job Viewed

Tap Again To Close

Job Description

full time

Are you an experienced Regulatory Affairs Manager looking to make a impact in the chemical manufacturing industry? We are seeking a proactive and detail-oriented professional to lead the regulatory strategy and ensure full compliance across site operations.

As a Regulatory Affairs Manager , you will play a critical role in navigating complex regulatory environments, working cross-functionally with R&D, production, quality, and commercial teams to support product compliance and market access. Your expertise will directly influence the ability to innovate safely and responsibly.

Key Responsibilities of Regulatory Affairs Manager :

  • Serve as the primary Regulatory Affairs Manager for all chemical regulatory matters, including REACH, TSCA, SEPA and other global compliance frameworks.
  • Prepare, submit, and maintain product registration dossiers and regulatory filings.
  • To complete the REACH registration of the full product range within the time limits set by ECHA.
  • Work closely with the SHE Manager and operations to ensure that the manufacturing process, human health and environmental exposure meet the scope of the CSR for each registered product.
  • Maintain material safety data sheet for all products which conform to the legislative requirements of both the U.K. and the countries into which the products are sold.
  • Collaborate closely with internal stakeholders to integrate regulatory requirements into product development and manufacturing processes.
  • Represent the company with regulatory agencies and industry associations.
  • Interpret regulatory legislation as applied to chemical entities so that the company can achieve its registration requirements in full, on time and at the most efficient cost; Monitoring and interpreting regulatory changes, advising the business on potential impacts

Qualifications required from Regulatory Affairs Manager :

  • Bachelor's degree or higher in Chemistry, Chemical Engineering, Regulatory Affairs, or related field.
  • Minimum 3-5 years' experience in regulatory affairs within chemical manufacturing.
  • Working knowledge of international chemical regulations and compliance systems.
  • Strong communication and interpersonal skills-ability to work well with people across all levels of the organisation.

What We Value:

We're looking for someone who not only excels in as a Regulatory Affairs Manager but also thrives in a team-oriented environment and helps foster a positive, values-driven workplace.

This is a chance to join a company that values innovation, and strong relationships. If you're ready to bring your regulatory expertise to a team where culture matters, we'd love to hear from you.

Apply today to become our next Regulatory Affairs Manager and help shape the future of safe, sustainable chemical manufacturing.

This advertiser has chosen not to accept applicants from your region.

Regulatory Affairs Manager

Covingham, South West ThermoFisher Scientific

Posted 13 days ago

Job Viewed

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Job Description

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
**Regulatory Affairs Manager**
Swindon, UK/Full time
**Work Schedule**
Standard (Mon-Fri)
**Job Description**
**Responsibilities:**
Join Thermo Fisher Scientific Inc. as a Manager, Regulatory Affairs, and play a pivotal role in moulding our regulatory strategies!
+ Perform regulatory surveillance
+ Assess regulatory feasibility of any new request (primary focal point) and address local impact.
+ Establish centre of expertise to be shared within Thermo Fisher network.
+ Externally, participate to working groups within professional bodies.
+ Supervise the maintenance of all official authorisations (MIA human and veterinary & MIA IMP - MS - ISO - GMP certificate) and establishment master documentations (SMF - DMF - device technical file) collaborating with appropriate regulatory agencies.
+ Ensure inspections & key audits readiness and/or participate.
+ Responsible for archiving official documents.
+ Supervise the maintenance of regulatory data bases (Client product registration information, components).
+ Ensure integration of registration information into Production and Quality master documents (process and QC specifications).
+ Participate to the Change Control process by defining regulatory requirements.
+ Acknowledge regulatory quotations and follow-up on invoices for reporting of financial indicators.
+ Identify areas of regulatory business opportunities (PDS and others).
+ Provide regulatory guidance (strategy definition, requirements assessment).
+ Coordinate the authoring of CMC/Quality documentations (gap analysis, IND-IMPD, NDA/BLA-MAA, registration questionnaires, pharmaceutical declarations) and review.
+ Supervise Client registration life-cycle activities (renewals, MoH questions).
**Requirements:**
To be successful in this role, you must possess experience in regulatory affairs, particularly within the legal framework. You should have:
+ B.Sc. or equivalent experience in Pharmacy, Chemistry, or Microbiology, or related science
+ A minimum of **7** years hands-on theoretical and practical regulatory affairs (including filling activities) as well as site regulatory compliance activities.
+ UK, European, US & International main pharmaceutical regulations (including GMPs). Knowledge of the workings of UK Ministry of Health.
+ Deep knowledge of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements
+ Dynamic, self-motivated, pro-active approach to taking on challenging assignments.
+ Strong communication and collaboration skills
+ Ability to work with critical timelines.
+ Outstanding communication skills, both written and oral, and the self-confidence to use these skills to convince others to buy-into proposals and plans.
We offer a range of flexible benefits including Pension and Healthcare in addition to competitive salaries.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
This advertiser has chosen not to accept applicants from your region.

Regulatory Affairs Manager

Witney, South East Abbott

Posted 13 days ago

Job Viewed

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Job Description

**Regulatory Affairs Manager**
**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 Regulatory Affairs Manager 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**
You will set the EU Regulatory Strategy that is well-defined and effective. The strategy sets out innovative solutions to Regulatory Approval so that plans can be set out.
You will oversee the Project Management of regulatory projects, integrating with the US and OUS Regulatory organisation, the R&D organisation and other key functional groups.
**Core Job Responsibilities**
+ Ensures maintenance of strong communication and working relationships with the Alameda RA group and other RA teams globally.
+ Ensures maintenance of strong communication and working relationships with the Clinical Affairs organisation, R&D Development groups and US Project Management.
+ Supports the interface and guidance of any external auditors such as FDA and ISO assessors reviewing Technical Files.
+ Provides leadership on Notified Body strategy and regional/global planning of product registration.
+ Responsible for defining the regulatory strategy for product approvals in EU and region.
+ Each new development project (product) requires a regulatory strategy to be created and maintained.
+ Responsible for supporting RA compliance with site EHS policy and procedures.
+ Responsible for maintaining the effectiveness of the Quality System at the site in accordance with Abbott Corporate requirements and applicable regulations.
+ Excellent communication / negotiating skills for discussions with Notified Bodies and Competent Authorities etc.
**Position Accountability / Scope**
+ Responsible for ensuring that products designed, changed or purchased by ADC in Europe meet the quality and regulatory standards as required by regulatory, quality, Abbott Corporate and national requirements.
+ This position must ensure that the products are registered in the countries as appropriate and ensure compliance to QS Regulations, ISO regulations, etc.
+ Responsible for ensuring that products designed, changed or purchased by ADC in Europe meet the quality and regulatory standards as required by regulatory, quality, Abbott Corporate and national requirements.
**Minimum** **Education**
+ Minimum of a Bachelor's degree or equivalent preferably in a Scientific discipline e.g. Chemistry, life Sciences, Biology.
**Minimum** **Experience/Training Required**
+ Minimum of a bachelor's degree is required to ensure that the jobholder has sufficient technical knowledge to effectively and confidently be the Regulatory Affairs Project Mgr in the EMEA region.
+ Knowledge of regulatory requirements for ISO 13485, EMC, MDD (93/42/EEC), IVDD (98/79/EC), MDR 2017/745 & IVDR 2017/756, and FDA Quality Systems Regulations is essential.
+ Experience within a medical or healthcare manufacturing industry in a regulatory role. The position requires an understanding of the needs of the customer and knowledge of regulations and standards affecting IVDs and MDDs, the regulatory bodies and country regulations that govern ADC products to enable the jobholder to interpret and apply regulations and standards to products and processes.
+ You need to have excellent written and oral communication skills necessary to be able to produce succinct reports and documentation and to effectively communicate with other departments, managers and external regulatory organizations.
+ You need to have the depth of Regulatory knowledge to be able to define a Regulatory Strategy that is well defined and effective. Additionally, the depth of experience is required to ensure that innovative solutions to Regulatory Approval paths can be set out.
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
This advertiser has chosen not to accept applicants from your region.
 

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