GxP Regulatory Intelligence Associate

About the role

The GxP Regulatory Intelligence Associate will support HRLeverage Kenya Limited by monitoring and analysing regulatory developments across 47 countries in the Middle Africa region. The role ensures that relevant changes are identified, assessed and communicated to cross‑functional GxP teams to maintain compliance and support business decisions.

Key responsibilities

• Proactively collect regulatory intelligence from competent authorities, government bodies, agencies and official publications.
• Track various intelligence types such as acts, guidelines, forms, circulars, memos, drafts and final documents.
• Engage with local regulatory agents, distributors and industry associations to supplement formal sources.
• Assess relevance, impact level, urgency and compliance obligations of each intelligence item for the company’s product portfolio.
• Perform gap analyses and prioritize actions based on business risk and implementation timelines.
• Prepare and distribute regulatory intelligence reports, alerts and impact assessment documents to Regulatory Affairs, Pharmacovigilance, Marketing, Medical Affairs, Supply Chain, and Quality Assurance.
• Present findings in cross‑functional meetings, governance forums and leadership reviews.

Required profile

• Minimum 36 months of experience in regulatory intelligence or related GxP functions.
• Familiarity with regulatory frameworks and documentation in the Middle Africa region.
• Ability to evaluate regulatory changes and determine their operational impact.
• Strong written communication skills to tailor reports for different functional teams.

Required skills