Regulatory Affairs Executive

Regulatory Affairs Executive responsible for executing business-aligned regulatory filing strategies with regional and local stakeholders to meet product launch deadlines. Manages preparation and submission of New Marketing Authorisation applications (National/DCP/MRP/CP), MA variations, and changes of ownership, along with educational materials and risk minimisation measures. Oversees launch-enabling regulatory activities such as RMP registration and artwork approvals, liaises with MHRA to address queries, and coordinates with internal/external partners to ensure timely responses. Handles artwork texts, CAPAs, regulatory archives, summaries of product characteristics, and regulatory support for medical information, patient safety, and audits. Works with launch teams to map regulatory progress for product launches and coordinates re-introduction of licenses, labeling changes, and regulatory applications as required. Maintains compliance with global/local SOPs and contributes to strategic opportunities in regulatory affairs.