Regulatory Affairs Executive

Manage regulatory activities to ensure compliance with requirements and maintain an inspection-ready culture. Develop local regulatory strategies, handle Agency submissions and questions, and prepare submissions including MAA, ILAP, IP, and UK PIPs. Review regulatory variation documentation, monitor project deadlines for escalation, and distribute local labelling documents following approvals. Implement Risk Management Plans and coordinate cross-functional teams for updates. Act as a subject matter expert by authoring SOPs, collecting competitive intelligence, and contacting Health Authorities to resolve queries. Mentor junior colleagues and proactively share regulatory insights to shape brand strategy.