Maintain WEP Regulatory Databases, ensuring that all country summaries are up to date and periodically reviewed in a timely manner.
Conduct structured regulatory research on defined topics to support project-specific regulatory planning and programme execution.
Monitor regulatory authority websites, subscribed intelligence platforms, and industry publications to identify relevant regulatory updates and emerging changes.
Support the coordination of external regulatory intelligence vendors by tracking deliverables and ensuring outputs are shared appropriately with internal stakeholders.
Review and interpret regulatory information to identify key requirements and considerations, summarising findings in clear, structured documentation for use by regulatory and cross-functional teams.
Identify potential regulatory changes, risks, or uncertainties and escalate findings to regulatory project leads or managers for further assessment and decision-making.
Support communication with regulatory authorities, where appropriate and under supervision, to clarify or validate country-specific regulatory information.
Support cross-functional discussions by providing regulatory intelligence inputs relevant to project delivery, compliance obligations, and programme design.
Identify opportunities for improved efficiency, consistency, or clarity in regulatory intelligence activities and propose improvements to senior team members.

Bachelor’s degree required, preferably in a health or science-related field
1–2 years of experience in a regulated healthcare environment such as a CRO, biotechnology, pharmaceutical, or similar regulated organization
Foundational understanding of regulatory pathways across the product lifecycle, including clinical development, early access, and commercial supply
Exposure to global regulatory frameworks including EU/UK, US FDA, and other international markets
Ability to interpret regulatory guidance, legislation, and authority communications and distill key requirements and implications
Experience supporting regulatory intelligence tools, databases, or structured regulatory trackers
Strong research, analytical, and summarization skills with high attention to detail
Proven ability to manage multiple priorities, meet deadlines, and work effectively in a fast-paced, ambiguous environment
Excellent written and verbal communication skills with strong organizational abilities and discretion in handling confidential information
Proficient in Microsoft Office, highly self-motivated, collaborative, and driven toward continuous process improvement

Regulatory Affairs Intelligence Associate

Key skills