7 Senior Regulatory Writer jobs in the United Kingdom
Senior Regulatory Writer
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Complete Regulatory is part of IPG Health Medical Communications, who is home to the world’s most celebrated and awarded Med Comms agencies. We are 800 experts obsessed with combining science, creativity, and technology to create exceptional medical communications solutions for our clients.
What do we do?
We provide class-leading writing support and consultancy services to the pharmaceutical industry, producing a wide range of high-quality clinical documentation, including clinical study reports, protocols, clinical summaries, clinical overviews, regulatory responses and other supporting documents, across a variety of therapy areas.
The role
We are looking to recruit Senior Regulatory Writers with at least 3 years' experience as a regulatory writer within the pharmaceutical industry and/or a medical writing agency. Applicants should be life-science graduates, ideally with a PhD or other research experience, although this is not mandatory.
You will use your thorough knowledge of FDA, EMA and ICH guidelines to write a wide range of regulatory documents; these will include strategic requirements, such as clinical overviews, higher-level summaries and briefing documents. You will also help to maintain our excellent client relationships, which will allow you to consult with the client and demonstrate your high-level strategic thinking, based on extensive past experience, to ensure effective medical writing for regulatory authorities.
You will be a highly valued member of the Regulatory Writing team and will have the opportunity to advance your skills while helping less experienced team members to achieve their potential, by providing coaching and insight.
What will you get in return?
This position will benefit anyone looking to build on their experience in regulatory writing, while working within a highly specialised, supportive and reputable team. In addition, you will become part of a larger organisation, which offers a range of world-class services and a flexible organisational structure.
As well as a fresh challenge in your career, long term career choices and development, you will be rewarded with:
· Flexible Time Off – uncapped paid time off
· Retail and gym discounts
· Great training and development
· Employee assistance programme
· Private healthcare
· Headspace and MYNDUP - a mental health wellness programme
· Cycle to work scheme
· Season Ticket Loan
· Flexible working
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.
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Senior Regulatory Writer
Posted today
Job Viewed
Job Description
Who are we?
Complete Regulatory is part of IPG Health Medical Communications, who is home to the world’s most celebrated and awarded Med Comms agencies. We are 800 experts obsessed with combining science, creativity, and technology to create exceptional medical communications solutions for our clients.
What do we do?
We provide class-leading writing support and consultancy services to the pharmaceutical industry, producing a wide range of high-quality clinical documentation, including clinical study reports, protocols, clinical summaries, clinical overviews, regulatory responses and other supporting documents, across a variety of therapy areas.
The role
We are looking to recruit Senior Regulatory Writers with at least 3 years' experience as a regulatory writer within the pharmaceutical industry and/or a medical writing agency. Applicants should be life-science graduates, ideally with a PhD or other research experience, although this is not mandatory.
You will use your thorough knowledge of FDA, EMA and ICH guidelines to write a wide range of regulatory documents; these will include strategic requirements, such as clinical overviews, higher-level summaries and briefing documents. You will also help to maintain our excellent client relationships, which will allow you to consult with the client and demonstrate your high-level strategic thinking, based on extensive past experience, to ensure effective medical writing for regulatory authorities.
You will be a highly valued member of the Regulatory Writing team and will have the opportunity to advance your skills while helping less experienced team members to achieve their potential, by providing coaching and insight.
What will you get in return?
This position will benefit anyone looking to build on their experience in regulatory writing, while working within a highly specialised, supportive and reputable team. In addition, you will become part of a larger organisation, which offers a range of world-class services and a flexible organisational structure.
As well as a fresh challenge in your career, long term career choices and development, you will be rewarded with:
· Flexible Time Off – uncapped paid time off
· Retail and gym discounts
· Great training and development
· Life assurance
· Pension
· Employee assistance programme
· Private healthcare
· Headspace and MYNDUP - a mental health wellness programme
· Cycle to work scheme
· Long Service Award
· Season Ticket Loan
· Flexible working
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.
Senior Regulatory Writer
Posted today
Job Viewed
Job Description
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.
Regulatory Medical Writer
Posted today
Job Viewed
Job Description
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.
Regulatory CMC Writer
Posted today
Job Viewed
Job Description
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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Principal Regulatory Medical Writer
Posted 524 days ago
Job Viewed
Job Description
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
Senior/Principal Regulatory Medical Writer (client-embedded) EMEA
Posted 8 days ago
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Job Description
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
Summarized Purpose:
We are excited to be expanding our Medical Writing FSP Team in Europe. We are looking for a Principal Medical Writer to be dedicated to a client in the FSP space; experience in leading submissions would be preferred. We are seeking an experienced and highly skilled Regulatory Medical Writer to join our team. The role is be responsible for creating, reviewing, and managing a wide range of clinical and regulatory documents. This role requires a strong understanding of scientific concepts, exceptional writing skills, and the ability to communicate complex information clearly and concisely.
Key Responsibilities:
· Lead the development, writing, and editing of complex clinical and regulatory documents, including clinical study reports, protocols, investigator brochures, and regulatory submissions (e.g., INDs, NDAs, MAAs).
· Collaborate with cross-functional teams, including clinical development, regulatory affairs, biostatistics, and medical affairs, to ensure the accurate and timely completion of documents.
· Ensure documents align with regulatory guidelines, company standards, and industry best practices.
· Provide strategic input and guidance on document content, structure, and presentation.
· Mentor and provide oversight to junior medical writers and ensure high-quality deliverables.
· Manage multiple writing projects simultaneously and prioritize tasks effectively.
· Stay current with industry trends, guidelines, and regulatory requirements.
Education and Experience:
· Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification required; Advanced degree preferred.
· Regulatory writing experience that provides the knowledge, skills, and abilities to perform the role (comparable to 8+ years).
· Experience working in the pharmaceutical/CRO industry required.
· Experience in managing and directing complex medical writing projects required.
· EU CTR experience preferred.
· Experience working on structured content management system and AI-driven content creation, and familiarity with Natural Language Generation preferred.
Knowledge, Skills, and Abilities:
· Excellent organizational and program management skills
· Proven leadership skills to manage and mentor a team of medical writers.
· Extensive knowledge of regulatory guidelines and drug development processes
· Strong interpersonal and communication skills to build and maintain effective working relationships with colleagues and stakeholders
· Understanding of quality control processes to ensure compliance with regulatory requirements and internal standards
· Self-motivated and adaptable
· Excellent judgment; high degree of independence in decision making and problem solving
· Capable of mentoring and leading junior level staff
What We Offer:
At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We have grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.
Our Mission is to enable our customers to make the world healthier, cleaner, and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
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.
Regulatory Content Strategist (Medical Writer)
Posted 3 days ago
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Job Description
**The Position**
A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come.
Creating a world where we all have more time with the people we love.
That's what makes us Roche.
The Pharma Development Regulatory (PDR) is a flexible, bold, and distinctive regulatory organization. We make decisions quickly and strategically as the environment & landscape evolves. We innovate. Within the PDR Data and Content Chapter, we are responsible for end-to-end data interpretation, generation and execution of content strategy, insight generation to guide submission strategy, and leadership of submission planning and management for clinical projects in the Roche portfolio in order to develop and maintain Roche product permits/licenses to meet the needs of our patients. We understand how data and information contribute to the strategy and quality of submissions, and thus, deliver high-quality submissions to global Health Authorities for products throughout their development lifecycle to facilitate reviews and approvals. We ensure audit and inspection readiness and representation. Additionally as a member of PDR, individuals understand how data and information contribute to the quality of our submissions
As a member of this Chapter, you will drive and manage data interpretation and content, including medical writing, from initiation to approval, developing data and content standards, driving and articulating key messages, content creation, strategic reuse of content, and implementing automation and next-generation systems and tools. Additionally, you may participate in industry associations to shape and influence data, content, technology, and submission standards.
**The Opportunity:**
+ Assists with the preparation of regulatory content in accordance with applicable regulatory guidelines/Roche standards/SOPs. Regulatory content may include the Clinical Dossier and/or Suite of Safety reports for drugs or medical devices
+ Plans content and creates timelines for the production and review of documents ensuring alignment with overall project timelines where appropriate
+ Reviews documents for organization, clarity, scientific standards, and consistency of content, data, and messaging. Resolves issues with cross-functional contributors. Ensures compliance with regulatory requirements
+ Manages the review and approval process
+ Ensures that documents are published in collaboration with Regulatory Operations
+ Is a key strategic participant in functional and cross functional teams and actively contributes to best practices and continuous improvement initiatives and projects
+ Maintains up-to-date knowledge of key regulatory, scientific, and medical topics relevant to drug development, assigned products, and disease/therapeutic areas
**Who you are:**
+ Degree in Life Sciences or equivalent with proven experience in the pharmaceutical/biotechnology industry, demonstrating independent project delivery and leadership.
+ Proficient in G Suite, Microsoft Office Suite, Adobe Acrobat, and Veeva Vault.
+ Familiarity with regional/global drug development processes, regulations, and guidelines (e.g., GxP, GCP, ICH) and an understanding of GVP and GCP principles, including data integrity.
+ Strong communication and interpersonal skills, effective collaboration within scientific cross-functional and matrix-based environments, with a strong sense of urgency.
+ Ability to work with minimal supervision, excellent administrative and project planning skills, detail-oriented, creative thinker with a curiosity to learn and adapt to change, and fluent in English (verbal and written).
**Our team follows a hybrid work structure (majority of days on-site is required).**
**Relocation benefits are not available for this job posting.**
**Who we are**
A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let's build a healthier future, together.
The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd. At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants' requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.
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