Regulatory Documentation Specialist
13 hours ago
We are seeking a highly skilled Regulatory Documentation Specialist to join our team in the UK. As a Senior Medical Writer, you will play a crucial role in producing high-quality regulatory documentation for the international pharmaceutical industry.
With a strong background in medical writing and a deep understanding of regulatory requirements, you will work closely with our clients to deliver exceptional results. Your expertise will ensure that all documents meet the highest standards, on time and within budget.
In this role, you will be responsible for:
- Preparing clinical regulatory documents, including Clinical Study Protocols, Clinical Study Reports, and Investigator Brochures;
- Leading authoring teams to ensure timely delivery of high-quality documents;
- Coordinating review cycles, meetings, and project timelines to meet client needs;
- Providing document-specific advice to clients and ensuring compliance with relevant SOPs.
The ideal candidate will have:
- A minimum of 3 years of experience in medical writing, with a focus on regulatory documentation;
- A strong track record of delivering high-quality documents on time and within budget;
- Excellent written and communication skills, with the ability to interact effectively with clients and authors;
- Proficiency in using document management systems and review tools;
- A Bachelor's degree in science or pharmacy, with a strong foundation in regulatory affairs.
This is an excellent opportunity to join a dynamic team and contribute to the success of our clients. If you are a motivated and experienced Regulatory Documentation Specialist looking for a new challenge, we encourage you to apply.
-
Regulatory Documentation Specialist
3 weeks ago
London, Greater London, United Kingdom Wellington Management Company, LLP Full timeAbout the RoleWe seek an experienced professional to join our Investment Product and Fund Strategies (IPFS) group as a Regulatory Documentation Specialist. In this role, you will be responsible for creating, overseeing, and maintaining regulatory documentation for the WMF Global business.Responsibilities:Prospectus Cycles: Manage the end-to-end process for...
-
Regulatory Document Specialist
3 weeks ago
London, Greater London, United Kingdom MMS Holdings Inc Full timeMMS Holdings Inc is a leading CRO that supports the pharmaceutical, biotech, and medical device industries with a data-focused approach to complex trial data and regulatory submission challenges.Job SummaryWe are seeking an experienced Regulatory Document Specialist to join our team. This role will involve critically evaluating, analyzing, and interpreting...
-
Senior Regulatory CMC Document Specialist
11 hours ago
London, Greater London, United Kingdom RBW Consulting Full timeJob Title: Senior Regulatory CMC Document SpecialistAt RBW Consulting, we are seeking a highly skilled Senior Regulatory CMC Document Specialist to join our team. In this pivotal role, you will be instrumental in preparing and submitting high-quality CMC regulatory documents to support registration activities for both small molecule and biopharmaceutical...
-
Regulatory Affairs Strategist
3 weeks ago
London, Greater London, United Kingdom VRS Regulatory Full timeRole OverviewA challenging opportunity has arisen for a Regulatory Affairs Strategist to join VRS Regulatory's team. About the RoleWe are seeking an experienced Regulatory Affairs Strategist to develop and implement regulatory strategies for plant protection products in specific geographical territories. Develop and execute regulatory strategies for product...
-
Senior CMC Regulatory Document Specialist
3 weeks ago
London, Greater London, United Kingdom RBW Consulting Full timeJob TitleSenior CMC Regulatory Document SpecialistAbout the RoleThis pivotal position is instrumental in preparing and submitting high-quality CMC regulatory documents to support registration activities for both small molecule and biopharmaceutical therapeutic assets.Key ResponsibilitiesPrepare, review, and finalize regulatory submission documents for...
-
Regulatory Documentation Lead
6 hours ago
London, Greater London, United Kingdom Albion Rye Associates Full time**Job Description:**We are seeking a highly skilled Regulatory Documentation Lead to join our team at Albion Rye Associates. The ideal candidate will have extensive experience in regulatory writing, clinical research, and leadership, with a strong understanding of regulatory requirements across all phases of development and pathways.Responsibilities:Prepare...
-
Regulatory Document Writer
12 hours ago
London, Greater London, United Kingdom Richmond Pharmacology Full timeRichmond Pharmacology is a leading Contract Research Organisation (CRO) that specialises in early-phase clinical trials for pharmaceutical and biotechnology sponsors.We offer a competitive salary of £55,000 - £70,000 per annum, depending on experience, as well as benefits such as private medical insurance, pension scheme, and 25 days annual leave plus bank...
-
Regulatory Document Author
10 hours ago
London, Greater London, United Kingdom Richmond Pharmacology Full timeKey ResponsibilitiesWrite and review various clinical and regulatory documents such as clinical study protocols (CSPs), clinical study reports (CSRs), informed consent forms (ICFs), summary documents, advertising material and regulatory responses. Collaborate with other senior writers and sponsors to develop and execute communication plans. Ensure all...
-
Regulatory Document Creator
3 weeks ago
London, Greater London, United Kingdom Emagine Consulting Full timeJob OverviewA Document Writer at Emagine Consulting plays a crucial role in creating comprehensive documents for regulatory submission, summarizing compliance requirements. This dynamic individual will collaborate with subject matter experts to document processes and actions taken to meet regulatory frameworks such as MiFID, Basel III, FRTB, and more.The...
-
London, Greater London, United Kingdom VRS Regulatory Full timeEstablished chemical regulatory science consultancy is seeking a delivery-focused Regulatory Affairs Specialist to cover an increasing workload.This role will take the lead on physical/chemical properties/analytical methods and method validation for plant protection products. Key responsibilities include:Providing clients with regulatory advice on substance...
-
Regulatory Compliance Specialist
3 weeks ago
London, Greater London, United Kingdom Regulatory Affairs Professionals Society Full timeJob DescriptionAs a Regulatory Affairs Manager at Prinova Europe, you will oversee regulatory strategy for the organisation, providing leadership and guidance to the business on regulatory matters for food, feed and personal care activity in the UK and other markets where Prinova Europe and Prinova Solutions Europe operates.This role involves ensuring...
-
Regulatory Documentation Expert
10 hours ago
London, Greater London, United Kingdom Richmond Pharmacology Full timeJob Description: We are recruiting a highly skilled Medical Writer to join our team at Richmond Pharmacology. The ideal candidate will have at least 2 years of relevant clinical/regulatory medical writing experience and excellent written and verbal communication skills. Key Responsibilities: Develop diverse materials across various therapeutic areas,...
-
CMC Regulatory Documentation Expert
7 hours ago
London, Greater London, United Kingdom RBW Consulting Full timeJob Description: We are looking for a highly skilled CMC Regulatory Documentation Expert to join our team at RBW Consulting. In this role, you will be responsible for preparing and submitting high-quality CMC regulatory documents to support registration activities for both small molecule and biopharmaceutical therapeutic assets.Responsibilities:- Prepare,...
-
Regulatory Medical Specialist
3 weeks ago
London, Greater London, United Kingdom Medicines and Healthcare Products Regulatory Agency Full timeCompany OverviewThe Medicines and Healthcare Products Regulatory Agency is a leading organization in the field of medical regulation, working to protect public health through the effective regulation of medicines and medical devices.About the RoleWe are currently seeking a Regulatory Medical Specialist to join our team within the Safety and Surveillance...
-
Regulatory Document Specialist
7 hours ago
London, Greater London, United Kingdom Albion Rye Associates Full timeAbout UsAlbion Rye Associates is a leading provider of drug development and regulatory science services. We partner with biopharmaceutical companies to help bring critical drug products to patients.We are seeking an experienced Regulatory Writer / Head of Medical Writing to join our team in London (hybrid working). As a key member of our team, you will work...
-
Regulatory Affairs Specialist
7 hours ago
London, Greater London, United Kingdom X4 Life Sciences Full timeJob Title: Regulatory Affairs SpecialistA medical device company in London is seeking a highly skilled Regulatory Affairs Specialist to support their growth. This role involves managing technical files, dossiers, and regulatory documents for Class 1 Measuring Devices.Responsibilities include:Oversee the development and management of technical files,...
-
Regulatory Affairs Director
4 weeks ago
London, Greater London, United Kingdom Reed Specialist Recruitment Ltd Full timeJob OverviewWe are seeking an experienced Regulatory Affairs Manager to join our team at Reed Specialist Recruitment Ltd.Estimated Salary: £65,000 - £80,000 per annum, depending on experience.Key Responsibilities:Develop and Implement Regulatory Strategies: Create and execute regulatory plans aligned with our company's objectives.Lead the Regulatory...
-
Documentation Control Specialist
3 weeks ago
London, Greater London, United Kingdom Johnson & Associates Rec Specialists Ltd Full timeAbout the RoleJohnson & Associates Rec Specialists Ltd is seeking an experienced professional in loan documentation to join their prestigious bank in London as an Assistant Vice President in the Execution Control Team.We offer a competitive salary of up to £70,000 and a hybrid working structure, allowing you to strike a perfect balance between work and...
-
Regulatory Affairs Specialist
3 weeks ago
London, Greater London, United Kingdom Hyper Recruitment Solutions Ltd Full timeJob Title: Regulatory Affairs SpecialistAbout the RoleThis is an exciting opportunity to join our prestigious healthcare organisation as a Regulatory Affairs Specialist. Based in London, you will play a pivotal role in ensuring compliance and approval processes for innovative medical solutions that have a significant impact on patient care.Your Key...
-
Regulatory Compliance Specialist
3 days ago
London, Greater London, United Kingdom Goldman Sachs Group, Inc. Full timeAbout the RoleWe're looking for a Regulatory Compliance Specialist to join our team at Goldman Sachs Group, Inc. In this role, you will be responsible for ensuring the firm's activities are conducted in compliance with regulations governing transactions in the financial markets.The ideal candidate will have strong organizational and project management...