135 Regulatory Writer jobs in the United Kingdom

Complete Regulatory is part of IPG Health Medical Communications , home to some of the world’s most celebrated and awarded med comms agencies. With over 800 experts globally, IPG Health Medical Communications is dedicated to combining science, creativity, and technology to deliver exceptional medical communications solutions.

What We Do

At Complete Regulatory, we offer industry-leading regulatory writing and consultancy services to pharmaceutical and biotechnology clients. We specialise in delivering high-quality clinical and regulatory documentation across a wide range of therapy areas, including:

• Clinical Study Reports (CSRs)
• Protocols and Amendments
• Clinical Summaries and Overviews (e.g., CTD Modules 2.5 and 2.7)
• Regulatory responses and briefing documents
• Other essential documentation for global submissions

The Role: Senior Regulatory Writer

We are seeking experienced Senior Regulatory Writers to join our growing team. You’ll play a key role in writing and reviewing a broad range of regulatory documents, with a particular focus on strategic, high-level submissions for global health authorities.

Key Responsibilities

• Develop and deliver high-quality regulatory documents in line with guidelines
• Lead the creation of complex documentation such as clinical overviews, summaries, and briefing packages
• Provide strategic consultancy to clients, demonstrating critical thinking and a deep understanding of regulatory requirements
• Maintain and enhance strong client relationships through effective communication and expert guidance
• Support and mentor junior writers, contributing to the development of internal expertise

What You’ll Bring

• A degree in a life sciences discipline (PhD or equivalent research experience is advantageous but not essential)
• Prior regulatory writing experience in the pharmaceutical industry, medical communications agency or CRO
• Strong understanding of global regulatory requirements and submission standards
• Excellent scientific writing, project management, and interpersonal skills
• A collaborative, flexible mindset and a drive for high-quality output

What You’ll Get in Return

This role offers an excellent opportunity to advance your career within a highly specialised and supportive team , while benefiting from the reach and resources of the wider IPG Health network.

You’ll also receive a competitive package, including:

• Flexible Time Off – uncapped paid leave
• Private healthcare and life assurance
• Pension scheme
• Employee Assistance Programme
• Headspace and MYNDUP – mental health and wellbeing resources
• Retail and gym discounts
• Training and professional development
• Cycle to work scheme
• Long Service Award
• Season ticket loan
• Flexible and hybrid working options

If you're looking for your next challenge in regulatory writing and want to be part of a high-performing, expert-led team, we’d love to hear from you.

To Apply or Contact Us

Apply by clicking the link below.

IPG Health Medical Communications is home to the world’s most celebrated and awarded med comms agencies, united by a healthy obsession with creating exceptional medical communications for our clients. Our people are the beating heart of our organisation, and through the positive culture we champion, our teams create communications that not only have a positive impact for our clients, but also impact on the world around us.

We celebrate diversity and encourage applicants from all whatever their background and/or disability. We want you to have every opportunity to shine and show us your talents, so please reach out and let us know if there are any reasonable adjustments we can make to ensure our assessment process works for you.

Complete Regulatory is part of IPG Health Medical Communications, home to the world’s most awarded and celebrated Med Comms agencies. With over 800 dedicated experts, we combine science, creativity, and technology to craft exceptional medical communications solutions for leading pharmaceutical companies worldwide.

What We Do

We specialize in regulatory writing and consultancy services, providing best-in-class support to the pharmaceutical industry. Our work spans a wide range of high-quality clinical and regulatory documents, including:

• Clinical Study Reports (CSRs)
• Protocols and Amendments
• Clinical Summaries and Overviews (for CTD Modules 2.5 & 2.7)
• Regulatory responses to health authorities
• Investigator’s Brochures and other supporting documentation

We work across a variety of therapy areas, partnering with clients at all stages of drug development and submission.

The Role: Regulatory Writer

We’re looking for experienced Regulatory Writers who are both clever and curious, with a passion for science and precision. You’ll play a key role in interpreting and communicating complex scientific data clearly and accurately for regulatory submissions worldwide.

Key Responsibilities

• Write, edit, and review regulatory documents in accordance with guidelines and client requirements
• Analyze and interpret scientific data to develop coherent and compliant narratives
• Collaborate with internal teams and clients to ensure high-quality, timely deliverables
• Manage multiple projects, timelines, and client expectations effectively
• Proactively resolve project-related issues and contribute to continuous improvement

What You’ll Bring

• A degree in a life sciences discipline (PhD or research experience preferred, but not essential)
• Prior regulatory writing experience in a medical communications company, CRO or Pharma
• A solid understanding of drug development and regulatory documentation requirements
• Excellent writing, communication, and organizational skills
• Ability to work both independently and collaboratively in a fast-paced environment

What You’ll Get in Return

This is an opportunity to advance your career in regulatory writing within a highly specialised, supportive, and reputable team, while benefiting from the broader offerings of IPG Health Medical Communications.

We offer a competitive rewards package, including:

• Flexible Time Off – uncapped paid leave
• Private healthcare and life assurance
• Pension scheme
• Mental health & wellness support – including Headspace and MYNDUP
• Training & development opportunities
• Retail and gym discounts
• Cycle to work scheme
• Season ticket loan
• Employee Assistance Programme
• Long Service Awards
• Flexible/hybrid working options

If you’re a detail-oriented writer who thrives on making complex science clear, and you're looking for a fresh challenge in a collaborative and forward-thinking environment, we’d love to hear from you.

To Apply or Contact Us

Apply by clicking the link below.

IPG Health Medical Communications is home to the world’s most celebrated and awarded med comms agencies, united by a healthy obsession with creating exceptional medical communications for our clients. Our people are the beating heart of our organisation, and through the positive culture we champion, our teams create communications that not only have a positive impact for our clients, but also impact on the world around us.

We celebrate diversity and encourage applicants from all whatever their background and/or disability. We want you to have every opportunity to shine and show us your talents, so please reach out and let us know if there are any reasonable adjustments we can make to ensure our assessment process works for you.

Shape your future with the freedom to work where you thrive! Join our client in this fully remote role that fits your life.

Proclinical is seeking a detail-oriented Regulatory Affairs CMC Writer to support the preparation of high-quality Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory submissions. This role focuses on authoring key sections of regulatory documents, including Module 2.3 (Quality Overall Summary), Module 3 (Quality), and CMC-specific content for Briefing Books used in Scientific Advice procedures with regulatory agencies.

Responsibilities:

• Draft and revise Module 2.3 (Quality Overall Summary) to ensure alignment with Module 3 and compliance with ICH guidelines.
• Prepare and update Module 3 (Quality) sections, covering drug substance, drug product, and control strategies based on source data and development reports.
• Author CMC-specific content for Briefing Books submitted to regulatory authorities for Scientific Advice procedures.
• Ensure all documents meet internal standards and regulatory requirements (e.g., EMA, FDA, ICH).
• Collaborate with internal CMC experts, QA, Regulatory Affairs, and external manufacturing partners to gather technical information.
• Align content across modules to maintain scientific consistency and regulatory clarity.
• Support regulatory strategy by providing scientifically sound CMC documentation aligned with the overall development plan.
• Contribute to responses to agency questions or follow-ups related to CMC topics.

Key Skills and Requirements:

• Background in Life Sciences, Chemistry, Pharmacy, or a related field (advanced degree preferred).
• Experience in CMC regulatory writing, including preparation of Modules 2.3, 3, and CMC sections of Briefing Books for EU and/or US regulatory submissions.
• Strong knowledge of ICH guidelines and EMA/FDA CMC requirements, including eCTD submission formats.
• Excellent writing, analytical, and communication skills in English.
• Ability to work independently in a remote or virtual team environment.
• High attention to detail with a focus on document structure and scientific clarity.
• Familiarity with document management systems and collaborative writing tools (e.g., Veeva, SharePoint) is a plus.
• Experience with biologics, cell and gene therapy, or complex injectables is advantageous.
• Prior engagement with regulatory agencies (e.g., EMA, FDA, MHRA) is preferred.
  

If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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Our client has been recognized by AMWA and EMWA as the best Global Medical Writing Consultancy. Having won several new projects with the market-leading Pharmaceutical Titans and Niche biotechs with NASDAQ funding, You will have an abundance of learning and Development opportunities to work on a variety of projects based on your preference.

This is an opportunity to work alongside VPs and Sr Directors who have been hand-picked and headhunted from the best pharmaceutical, CRO, and Medical Communications companies. You will receive training in all areas of Medical Writing to ensure you become the best and most well-rounded Medical Writing specialist possible. You will also be partnered with commercially minded specialists to support you in being sponsor-facing, leading projects and client meetings should this be an avenue you'd be itnerested in.

This is a remote-friendly role, allowing you to work from anywhere in Portugal.

Requirements

• 4+ years of regulatory medical writing experience in the biotech/pharma/Consultancy environment
• Extensive experience authoring regulatory documents for FDA and EMA submissions
• Expert knowledge of ICH guidelines and other regulations governing clinical trials
• Strong experience as Lead Writer on CTD's, CSR's or Clinical Protocols.
• Ability to work independently and collaborate cross-functionally in fast-paced environment
• Strong project management skills and ability to deliver high quality documents under tight timelines

Benefits

• L&D funding for Conferences, networking and workshops
• Annual Performance-Based Bonus
• WFH and Remote working flexibility
• Access to online training services

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

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• Preparing and managing regulatory documentation for a diverse product portfolio.
• Organising and maintaining compliant regulatory records as per industry standards.
• Tracking and reporting regulatory project progress to stakeholders.
• Keeping abreast of regulatory changes and communicating updates to internal teams.
• Monitoring industry trends to ensure ongoing compliance with pharmaceutical regulations.
• Supporting client communications related to regulatory processes and updates.

• A Bachelor’s degree in a scientific, healthcare, or related field.
• Proven experience in Regulatory Affairs within the pharmaceutical industry.
• Exceptional organisational skills and meticulous attention to detail.
• Strong written and verbal communication skills.
• Adaptability to evolving regulatory requirements.
• A collaborative spirit, excelling in team-oriented settings.
• Proficiency in standard office software (e.g., Microsoft Word, Excel, Outlook).
• A drive for professional development in regulatory affairs.
• Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP).

• Experience with regulatory submissions for new products or post-market changes.

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!

• The Regulatory Affairs Consultant EMEA (Self Care) is responsible for the development of regulatory strategies across the EMEA region, and globally as relevant, providing regulatory input and technical guidance on regulatory requirements to product development teams within the Self Care franchise.
• Evaluates and coordinates the regulatory deliverables for medicines and food supplements, within their geographical and/or brand area of responsibility.
• Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines.
• Tracks the status of applications under regulatory review and provides updates to the regulatory team.
• Works with local and regional regulatory colleagues to develop global and/or regional regulatory strategies, coordinating regulatory actions and results and develops global/regional dossiers to support local review processes

• Relevant Bachelor's Degree or higher in Life Sciences, Chemistry, Pharmacy
• Expertise across a broad spectrum of Regulatory classifications in particular medicine and food supplements in EMEA region
• Strong knowledge of regulatory frameworks and external environments, and the ability to apply these to regulatory solutions throughout the product lifecycle.
• Solid understanding of regulatory/medical/safety/quality requirements in the markets of relevance.
• In-depth knowledge of the business, organizational goals, Regulatory Affairs function, and cross functional business partners to make informed business decisions and create and execute business strategies. Ability to represent RA function on cross-functional teams and governance forums.

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