Docuvera Specialist - Regulatory Affairs (GSK Support)

Job Title: Docuvera Specialist - Regulatory Affairs (GSK Support)

Location: United Kingdom (Hybrid / Remote, UK-based)
Engagement: Contract or Permanent (via partner organisation)

Role Overview

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.

Required Skills and Experience Essential

• 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.

Desirable

• 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.

Education and Qualifications

• Degree in a scientific or life sciences discipline (or equivalent industry experience).
• Formal training in regulatory affairs, document management, or quality systems is advantageous.

Key Competencies

• 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

Additional Information

This role supports GSK indirectly through a partner organisation and requires adherence to both partner and GSK regulatory, quality, and compliance standards.