Technical Writer and Regulatory Consultant

4 weeks ago


London, United Kingdom RBW Consulting Full time

About the Position:

RBW Consulting is seeking a seasoned Senior CMC Regulatory Technical Writer to join our team. As a key member of our regulatory department, you will play a critical role in preparing and submitting high-quality CMC regulatory documents to support registration activities for both small molecule and biopharmaceutical therapeutic assets.

Key Responsibilities:

  • Prepare, review, and finalize regulatory submission documents for late-stage clinical applications (Phase 3) and marketing applications.
  • Write CMC sections of regulatory submissions, including Modules 2.3 and 3 of the CTD, and briefing documents for Health Authority consultations.
  • Collaborate with CMC teams (formulation, process development, analytical, and manufacturing) to gather necessary information.
  • Develop and maintain CMC regulatory dossier templates, ensuring compliance with evolving guidelines.
  • Manage CMC regulatory submission workflows within the document management system.
  • Ensure accuracy, consistency, and completeness of data and narratives in regulatory documents.
  • Oversee timelines and deliverables for multiple projects, communicating potential delays promptly.
  • Provide guidance and training to team members as needed.

Requirements:

  • Degree in Pharmacy, Chemistry, Biology, or a related field.
  • Around 10 years in a CMC role within the pharmaceutical industry, including at least 5 years in CMC regulatory submission technical writing.
  • In-depth knowledge of CMC-related regulatory requirements and guidelines (e.g., ICH, FDA, EMA) and experience with eCTD submissions.
  • Exceptional technical writing skills with the ability to clearly communicate complex scientific information.
  • Meticulous attention to detail and accuracy.
  • Strong organizational and project management skills to handle multiple tasks simultaneously.
  • Proficiency in MS Office applications and regulatory information management software (e.g., eCTD, Veeva).
  • Business level proficient in written and spoken English.

Why Join Us:

At RBW Consulting, we believe in creating a positive and inclusive work environment where our employees can thrive. We offer a competitive salary of €85,000 per year, plus benefits and opportunities for professional growth and development.

],

  • London, Greater London, United Kingdom writer Full time

    Job SummaryWe are seeking an experienced Pre-Sales Solutions Architect Manager to join our team at Writer. In this role, you will be responsible for managing and mentoring a team of Solution Architects, each with extensive knowledge and experience in Data and AI technologies.ResponsibilitiesCreate proof-of-concept demonstrations and build strong...


  • London, United Kingdom VRS Regulatory Full time

    An excellent opportunity for established or aspiring chemical regulatory professionals to join a leading EU chemicals risk management and policy consultancy. You will use your chemical regulatory science knowledge alongside economists and social scientists on a wide range of multi-disciplinary projects including REACH compliance, authorisations,...


  • London, United Kingdom RBW Consulting Full time

    Senior CMC Regulatory Technical Writer Are you a detail-oriented technical writer with a passion for regulatory science? Join a dynamic CMC Regulatory Department as a Senior CMC Regulatory Technical Writer. In this pivotal role, you will be instrumental in preparing and submitting high-quality CMC regulatory documents to support registration activities for...

  • Regulatory Writer

    3 weeks ago


    London, Greater London, United Kingdom RBW Consulting Full time

    Overview:RBW Consulting seeks a skilled Senior CMC Regulatory Technical Writer to prepare and submit high-quality regulatory documents. This is a freelance position with potential for renewal.About the Role:Prepare, review, and finalize CMC regulatory submission documents for late-stage clinical applications (Phase 3) and marketing applications.Develop and...


  • London, Greater London, United Kingdom RBW Consulting Full time

    Job Title: Senior Regulatory WriterThis role is responsible for preparing and submitting high-quality CMC regulatory documents to support registration activities for both small molecule and biopharmaceutical therapeutic assets. The ideal candidate will have a strong background in CMC regulatory science, technical writing skills, and experience in managing...


  • London, United Kingdom X4 Group Full time

    An independent pharmaceutical consultancy is seeking a Senior Regulatory Writers to support the Directors in leading the regulatory writing department. **Senior Regulatory Writer Role:** - Lead the preparation of clinical and regulatory documents: Protocols, Clinical Study Reports (CSRs), Investigator’s Brochures (IBs), Integrated Safety and Efficacy...


  • London, United Kingdom X4 Group Full time

    **The Company:** An international consultancy with offices in the UK, US and across Europe, recently became part of a large group of companies with a global outreach. Focused on providing highly specialised Medical Writing services to Pharmaceutical, Biotech and MedicalDevice clients. **Freelance Regulatory Writer Role:** - Prepare clinical and regulatory...


  • London, United Kingdom X4 Group Full time

    **The Company:** An international consultancy with offices in the UK, US and across Europe, recently became part of a large group of companies with a global reach in the pharmaceutical industry. Focused on providing highly specialised Medical Writing services to Pharmaceutical,Biotech and Medical Device clients. **Freelance Regulatory Writer Role:** -...

  • Technical Writer

    3 weeks ago


    London, United Kingdom Lorien Full time

    **Technical Writer** **5-month contract - Inside IR35** **£500 a day** **Key Responsibilities** - Create specialist documentation required to support delivery of training programmes - Collaboration with Product Managers, Engineers, Land Registration SMEs, Solution Architects, Learning and Development Consultants - Making sure system is user friendly -...


  • London, Greater London, United Kingdom writer Full time

    Job DescriptionAs a Technical Pre-Sales Lead at Writer, you will be responsible for delivering AI, ML, NLP solutions for clients across multiple industries, working with a Sales team to drive GTM motions, and architecting or deploying cloud-native solutions.You will also lead a customer-facing technical pre-sales Solutions Architect or Sales Engineering team...

  • Technical Writer

    2 months ago


    Remote, London , Remote, London, UK, United Kingdom RBW Consulting Full time

    Technical Writer – Analytical CMC Are you a detail-oriented technical writer with a passion for regulatory science and analytical development? Join a dynamic Regulatory Department as a Senior CMC Regulatory Technical Writer. In this pivotal role, you will be instrumental in preparing and submitting high-quality CMC regulatory documents to support...


  • London, United Kingdom CK Group Full time

    CK Group are recruiting for a permanent Senior Regulatory and Medical Writer to join a leading, dynamic and fast-growing consultancy on a permanent basis. They specialise in Advanced Therapies and Rare Diseases. This will be a fully remote role. RESPONSIBILITIES: Working as part of the medical writing team, you will be supporting the regulatory affairs,...


  • London, Greater London, United Kingdom Writer Full time

    About the RoleWe're looking for a results-driven leader to head our technical pre-sales team as a Solution Architect Manager. As a key member of our team, you'll be responsible for coaching and mentoring your team, identifying and addressing technical obstacles, and collaborating with the Sales team to develop business processes.Key...


  • London, United Kingdom VIQU Limited Full time

    ** Senior Technical Writer / Senior Technical Author - Remote in the UK - Permanent Calling all Senior Technical Writer / Senior Technical Author in the software industry! Growing software house is seeking a Senior Technical Writers / Senior Technical Author who comes from a software consultancy or the like to join their international tech team. We are...


  • London, Greater London, United Kingdom Vixio Regulatory Intelligence Full time

    Vixio Regulatory Intelligence Job Description**About Us**Vixio Regulatory Intelligence is the leading provider of regulatory intelligence. Our trusted insights and analysis give our clients a true picture of what's happening in an ever-changing landscape. We combine world-class content with advanced technology to help our clients make informed strategic...


  • London, Greater London, United Kingdom writer Full time

    About the RoleWe are seeking an experienced AI Solutions Architect Director to join our team at Writer. As a leader in this role, you will have the opportunity to manage and mentor a highly skilled group of Solution Architects, each with extensive knowledge and experience in Data and AI technologies.Your responsibilities will include empowering and enhancing...


  • London, Greater London, United Kingdom Vixio Regulatory Intelligence Full time

    Job Details: About VixioVixio Regulatory Intelligence offers innovative solutions to help businesses navigate the complex world of online gambling regulation.With a focus on delivering actionable insights and analysis, we empower our clients to make informed decisions, mitigate risks, and capitalize on opportunities.The RoleThis is a unique opportunity for...


  • London, United Kingdom Rise Technical Recruitment Limited Full time

    Excellent opportunity for a Technical Writer from the finance sector who is looking for a fully remote working role for an international market leading company. Do you have experience in technical writing for finance projects? Are you looking for an immediate start for an international market leader? This company have a global reach and are widely regarded...


  • London, Greater London, United Kingdom Publicis Groupe Holdings B.V Full time

    In the role of Regulatory Medical Writer at Publicis Groupe Holdings B.V, you will be responsible for developing accurate and engaging content for medical education materials while adhering to regulatory requirements. Strong communication skills and the ability to collaborate with clients and senior writers are essential for success in this position....


  • London, United Kingdom Rise Technical Recruitment Limited Full time

    Technical Writer (Renewable Energy) Remote Working - Anywhere in the UK £45,000 - £50,000 + Company Share Options + Healthcare + Progression Are you a Technical Writer from a Renewable, Oil & Gas or Industrial Engineering background? Excellent opportunity for a Technical Writer to join a cutting edge and market leading Renewable Energy technology...