Regulatory Information Systems Lead in Leeds

Regulatory Information Systems Lead

Global Rare Disease Biopharma – Fully Remote (UK / EU)

A highly specialised, fast-growing biopharmaceutical organisation focused on transforming the lives of patients with rare diseases is seeking an experienced Regulatory Information Systems Lead to join their global Regulatory Affairs function.

This company is driven by a mission to deliver meaningful impact for patients who are often underserved or overlooked. Their culture is built on collaboration, excellence, diversity, and a shared commitment to developing innovative therapies that truly make a difference. You’ll be joining a dynamic team of experts dedicated to overcoming challenges together, with a strong focus on patient‑centred solutions and continuous improvement.

The Role

As the Regulatory Information Systems Lead, you will oversee strategy, implementation, and optimisation across the full Veeva Vault RIM suite—Registrations, Submissions, Submissions Archive, and Publishing. You’ll act as the internal expert for Veeva system configuration, data governance, and process evolution, while supporting global regulatory compliance and major submission activities.

This role will work closely with the Global Head of Regulatory Affairs and cross‑functional stakeholders to ensure products are successfully registered, maintained, and supported across international markets.

Key Responsibilities

Veeva Vault RIM Leadership

• Lead implementation, configuration, and continuous optimisation of Veeva Vault RIM modules.
• Act as key user, trainer, and system owner, ensuring alignment with business needs and regulatory requirements.
• Oversee archiving and management of regulatory information and MA dossiers.

Data & Document Governance

• Lead data migration projects and ensure accuracy, consistency, and integrity across systems.
• Build custom reports, dashboards, and data models to support regulatory insights and decision‑making.

Regulatory Operations Support

• Coordinate global product registrations and lifecycle management, partnering with internal and external teams.
• Contribute to submission planning and preparation for major eCTD filings (IND / BLA / NDA / MAA).
• Support first registration and post‑approval submissions in collaboration with regulatory partners.

Regulatory Intelligence & Compliance

• Stay current on global regulatory requirements (US, EU, International) and ensure alignment within the RIM system.
• Monitor industry trends, legislative changes, and Veeva product updates to recommend improvements.

Reporting & Cross‑Functional Support

• Develop end‑user reports and provide ongoing internal support to stakeholders across the organisation.
• Assist with GxP inspections, CAPA closure, SOP development, and best‑practice implementation.

Required Skills & Experience

• 10+ years’ experience in regulatory information management within pharmaceutical regulatory affairs.
• Proven expertise across Veeva Vault RIM (Registrations, Submissions, Submissions Archive, Publishing).
• Experience in Veeva configuration, reporting, data modelling, and system optimisation.
• Strong understanding of global regulatory frameworks (eCTD, NeeS, IDMP, xEVMPD; CP, MRP, DCP, NP, NDA, IND, CTA, BLA).
• Solid experience working within FDA / EMA / ICH / GxP‑compliant environments.
• Excellent communication skills and ability to manage complex, cross‑functional projects.
• Fluency in English.

Desired

• Experience in eCTD publishing.
• Consulting background or strong influencing skills.
• Leadership capability with strategic and operational agility.
• Veeva Vault Certification(s).

Education

• Bachelor’s degree (or higher) in a scientific or related discipline.