Hyde End, England, United Kingdom
A regulatory labelling professional with ten years’ experience in the pharmaceutical industry. A subject matter expert in the labelling of innovative and generic medicinal products across different therapeutic areas. Coordinates and leads cross functional teams to update Company Core Datasheets (CCDSs), ensuring safety concepts are introduced effectively into local labelling. Excellent understanding of Global and European Economic Area (EEA) labelling requirements and experienced in managing product information for US and EEA Marketing Authorisations during applications (BLA/NDA/MAA) and throughout the lifecycle. Attained a MSc in Toxicology and a BSc (Hons) in Pharmacology. A flexible, organised approach to work with a keen eye for detail. Excellent written and oral communication skills with the ability to react positively and constructively to change.
• Provides expertise, leadership and guidance in the development, review and approval of CCDS and other key labelling documents. Resolves labelling issues with oversight committees. • Recommends labelling strategies for major labels (EU, JP, US). Drives consistency with the CCDS, the global product strategy, and Local Operating Companies’ (LOCs) requirements. Evaluates risks, authors outgoing communications. Develops mitigation plans and escalates issues to labelling management. • Provides labelling support to inspections, PBRERs, DSURs, Risk Management Plans (RMPs), and clients’ third party pharmacovigilance agreements. • Authors responses to health authority questions (FDA, EMA and worldwide) relevant to labelling topics. • Identifies and leads initiatives to enhance clients’ labelling processes and systems. • Manages and develops a talented team of three direct reports. Ensures resourcing, process training and performance management is adequate to attain clients’ and department’s objectives. • Recruited and trained new Labelling Associates for client roles, creating a training plan and material to ensure continuity and consistent practices for future team members.
Responsible for managing service team and activity. Ensured service department KPI’s were achieved and customer satisfaction levels exceeded. Maintained facility Quality and Health & Safety regulatory compliance. Developed good relations within the Company and all customers.