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- Tasks: Create and manage regulatory documents using Docuvera for pharmaceutical submissions.
- Company: Join a leading pharmaceutical support team with GSK.
- Benefits: Flexible hybrid/remote work, competitive pay, and career development opportunities.
- Why this job: Make a real impact in regulatory affairs while working with top industry professionals.
- Qualifications: Experience with Docuvera and understanding of regulatory documentation standards required.
- Other info: Dynamic role with opportunities for continuous improvement and professional growth.
The predicted salary is between 36000 - 60000 £ per year.
The Docuvera Specialist will provide regulatory documentation and publishing support to pharmaceutical regulatory affairs teams indirectly supporting GSK. The role requires hands‑on experience with Docuvera within a regulated pharmaceutical environment, ensuring the creation, lifecycle management, and submission readiness of regulatory documents in compliance with global health authority requirements.
The successful candidate will work closely with Regulatory Affairs, Quality, and Publishing teams to support high-quality, compliant regulatory submissions and ongoing document maintenance.
Key Responsibilities- Create, format, manage, and maintain regulatory documents using Docuvera in accordance with GSK and partner company standards.
- Support the preparation, publishing, and lifecycle management of regulatory documentation, including CTD and eCTD components.
- Ensure documents meet regulatory authority requirements (e.g. MHRA, EMA, FDA) and internal quality standards.
- Manage document version control, metadata, templates, and controlled vocabularies within Docuvera.
- Perform quality checks to ensure accuracy, consistency, formatting compliance, and submission readiness.
- Collaborate with Regulatory Affairs, Medical Writing, Publishing, and Quality teams to resolve document-related issues.
- Support regulatory submissions, variations, renewals, and responses to health authority queries.
- Maintain inspection‑ready documentation in line with GxP, SOPs, and document management best practices.
- Contribute to process improvements and continuous improvement initiatives related to document authoring and publishing.
- Proven hands‑on experience with Docuvera in a pharmaceutical regulatory affairs environment.
- Strong understanding of regulatory documentation standards, including CTD /eCTD structure and publishing requirements.
- Experience supporting regulatory submissions to MHRA, EMA, and/or FDA.
- Solid knowledge of GxP, document control, and quality systems.
- High attention to detail with strong document formatting and quality review skills.
- Ability to work effectively with cross‑functional, matrix teams.
- Excellent written and verbal communication skills in English.
- UK‑based with the right to work in the UK.
- Previous experience working on or supporting GSK regulatory projects.
- Familiarity with additional regulatory systems (e.g. Veeva Vault RIM, EDMS, submission publishing tools).
- Experience working within a CRO, consultancy, or vendor environment supporting large pharma clients.
- Understanding of change control, deviations, and CAPA processes within regulated environments.
- Degree in a scientific or life sciences discipline (or equivalent industry experience).
- Formal training in regulatory affairs, document management, or quality systems is advantageous.
- Regulatory compliance and quality focus.
- Strong organisational and time management skills.
- Ability to manage multiple documents and deadlines.
- Proactive problem‑solving and continuous improvement mindset.
- Professional integrity and confidentiality.
This role supports GSK indirectly through a partner organisation and requires adherence to both partner and GSK regulatory, quality, and compliance standards.
Docuvera Specialist – Regulatory Affairs (GSK Support) in London employer: Harrington Recruitment
Contact Detail:
Harrington Recruitment Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Docuvera Specialist – Regulatory Affairs (GSK Support) in London
✨Tip Number 1
Network like a pro! Reach out to folks in the regulatory affairs space, especially those who have experience with Docuvera. A friendly chat can open doors and give you insights that job descriptions just can't.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory standards and document management. Be ready to discuss how you've tackled challenges in previous roles, especially around compliance and quality checks.
✨Tip Number 3
Showcase your hands-on experience with Docuvera during interviews. Bring examples of how you've managed document lifecycles or improved processes in past roles. This will demonstrate your value to potential employers.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who are proactive about their job search!
We think you need these skills to ace Docuvera Specialist – Regulatory Affairs (GSK Support) in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to highlight your hands-on experience with Docuvera and any relevant regulatory affairs roles. We want to see how your skills align with the job description, so don’t hold back on showcasing your expertise!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for the Docuvera Specialist role. Share specific examples of your experience with regulatory submissions and document management that relate to GSK’s needs.
Showcase Your Attention to Detail: Given the nature of this role, we need to see your attention to detail in action. Make sure your application is free from typos and formatting errors. This is your first chance to demonstrate your quality review skills!
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It helps us keep track of your application and ensures you don’t miss out on any important updates. Plus, it shows you’re keen to join our team!
How to prepare for a job interview at Harrington Recruitment
✨Know Your Docuvera Inside Out
Make sure you brush up on your Docuvera skills before the interview. Be ready to discuss your hands-on experience and how you've used it in a regulatory affairs context. Highlight specific projects where you managed regulatory documents and how you ensured compliance with health authority requirements.
✨Understand Regulatory Standards
Familiarise yourself with the CTD/eCTD structure and the publishing requirements for submissions to agencies like MHRA, EMA, and FDA. During the interview, demonstrate your knowledge of these standards and how you've applied them in past roles. This will show that you're not just familiar with the tools, but also the regulations that govern their use.
✨Showcase Your Attention to Detail
Since this role requires high attention to detail, be prepared to provide examples of how you've maintained document accuracy and consistency in previous positions. Discuss any quality checks you've implemented and how they contributed to submission readiness. This will help convey your commitment to quality and compliance.
✨Collaborate Like a Pro
The role involves working closely with various teams, so highlight your experience in cross-functional collaboration. Share examples of how you've resolved document-related issues with Regulatory Affairs, Medical Writing, or Quality teams. This will illustrate your ability to work effectively in a matrix environment and your proactive problem-solving skills.
