Regulatory Insights Manager
Location: United Kingdom, Remote
The role:
We are looking for a highly organised and analytical Regulatory Insights (RI) Manager to contribute to the delivery of regulatory insights related to Early Access Programs (EAPs) and other pre-approval access routes.
In this role, the RI Manager will track and interpret global regulatory changes affecting the supply of unlicensed medicines, while maintaining a high-quality regulatory intelligence database that provides clear, reliable, and up-to-date information. The intelligence produced will enable teams across the organisation to make informed decisions and confidently navigate diverse regulatory environments to ensure compliant and timely access to medicines.
The position also involves safeguarding the accuracy and functionality of regulatory intelligence systems, overseeing data input processes, identifying opportunities for improvements, and supporting the delivery of client-driven work and projects.
What does the role entail?
* Act as the primary expert on regulatory intelligence for early access pathways.
* Oversee the regulatory intelligence database, ensuring information is current, accurate and reflects the latest regulatory expectations.
* Engage proactively with global health authorities to obtain detailed clarification on regulatory requirements. This includes planning and drafting targeted enquiries, managing follow-up, and using appropriate communication channels to secure precise and timely responses to complex questions.
* Prepare and deliver tailored intelligence reports, dashboards, and summaries for a range of internal audiences, including senior leadership.
* Regularly review and refine database content and ensure regulatory intelligence frameworks remain aligned with broader compliance, access and operational strategies.
* Provide support on client-facing projects requiring specialised regulatory intelligence, including the development of global summaries and databases related to early access, unlicensed medicines, and post-trial access.
* Direct client engagement, effective timeline management and delivering polished, high-quality outputs on schedule.
* Familiarity with AI-based tools and digital platforms to help ensure systems evolve to meet the needs of regulatory intelligence users.
Qualifications
* Bachelor’s degree in a life sciences related discipline; qualifications in Regulatory Affairs Sciences is preferred.
* Minimum of 5 years experience in the biotech/pharma setting, specialising in regulatory affairs or regulatory intelligence.
* Minimum of 3 years experience in EAP regulatory affairs.
* Experience in Market Access is highly desired.
* Knowledge of clinical trial regulations and post-trial access pathways.
Interviews will be conducted over a 2 stage process.