Global Regulatory program lead for the chronic local portfolio.

• Responsibility for EU and RoW markets including EE, CIS, APAC, MENA and LATAM, overseeing all submission, maintenance and launch activities related to Regulatory Affairs• Management of submission activities and health authority interactions, ensuring adherence to regulatory and quality standards and project timelines.• Provision of oversight of company documents and document systems supporting development activities.• Overseeing Regulatory Affairs Department staff and contractors.• Provision of oversight and management to external regulatory and development vendor resources.• Key contact with EMA regulatory project manager.• Ensuring adherence to Regulatory Affairs budget and achieving company regulatory goals according to agreed timelines and with a high level of quality.• Overseeing regulatory aspects of commercial product packaging, labeling and supply for EU countries.• Management of regulatory affairs aspects of commercial product labeling and supply for EU countries and other OUS regions as required.• Working with the EEA QPPV as the Deputy QPPV - Overview of the safety profiles and emerging safety concerns - Contribution to the maintenance of the PSMF - Development and review of key regulatory documents related to PV• Review key documents (e.g., clinical study protocols, labeling etc) to ensure adherence to regulatory requirements, guidance and GCP quality standards.• Provision of regulatory affairs project management including timelines and tracking of ongoing regulatory activities and supporting departmental budgeting activities.• Provision of input into assessments of emerging regulatory trends and precedents as to their potential impact to the business.

- Development of EU regulatory strategy towards the overall development of global regulatory strategy- Provision of strategic input to the global Regulatory team for all EU/RoW-based Regulatory Affairs matters including the seeking of Scientific Advice (national and centralised)- Define strategies for regulatory submissions for obtaining (CTA/MAA) and maintaining (amendments, variations, renewals, annual updates) approvals for drug products in EU countries; - Execution of the regulatory strategies through submission of regulatory documentation and contact with local Competent Health Authorities - Managing customisation of dossiers/CTAs for European countries, and organisation of the submission and registration of drug products in a compliant and timely manner - Serving as liaison with Regulatory Health Authorities (EMA and national authorities) - Educating project teams on regulatory pathways and requirements to ensure effective local product registrations - Maintenance of an adequate archiving system- Ensuring that the pharmaceutical products distributed in European countries meet the local regulatory requirements and support of the local sales and marketing organisations - Preparation of supportive documentation for Early Access Programmes in countries as required - Maintenance and development of knowledge of specific regulatory requirements in Europe - Provision of local or regional training on specific regulatory topics- Support of contractor selection and co-ordination of contracted activities

Project ManagementBusiness Development and Proposals Marketing Authorisation ApplicationsGlobal Marketing TransfersGlobal Development/StrategyOrphan Drug Applications Paediatric Investigation PlansScientific AdviceHealth Authority InteractionsGlobal Product Lifecycle MaintenanceLine Management

Project ManagerBusiness Development and Proposals Investigator Brochure WritingGlobal Development/StrategyGlobal Roadmap Development and WritingOrphan Drug Applications and MaintenanceScientific AdviceProduct Transfers and Dossier ComplianceHealth Authority InteractionsGlobal Marketing Authorisations and MaintenanceLine Management

Regulatory Business Development and Bid DefensesPhase IV Post approval studiesNon-interventional StudiesCommunicating with EU Health AuthoritiesMarketing Authorisation Applications (MAA) Module 1MAA Centralised ProceduresMAA ProposalsMAA StrategyEMA and Health Authority CorresspondanceClinical Trial Strategies and ProposalsClinical Trial Applications (South America, SE Asia, Europe, Russia, South Africa, Australia, New Zealand)Phase I, II and III Clinical TrialsClinical Trial Sponsor TransfersGlobal Regulatory Team LeadLocal Regulatory Affairs Expert for the UK and IrelandOrphan Drug DesignationsCompassionate Use ProgramsScientific Writing (IMPD, Module 2.7.3, Module 2.7.5, Scientific Briefing Packages for Health Authority Meetings)Project Finance and ManagementBusiness Proposals and Strategy