Thomas Hinnen

Project Management Office (PMO) within CHC Development Centre: -Project portfolio coordination, resource planning and stakeholder communication -Establish project management standards to facilitate efficient and robust execution -Track and provide project metrics (KPI) Development Project Lead: -Functional lead of multidisciplinary team (galenics, analytic, regulatory & quality) -Planning, tracking of deliverables, timelines and budget -Regular status reports, risk analysis & risk mitigation options

- Coordinate preparation & submission of dossiers, eg. new registrations, renewals, variations - Maintain integrated project plans related to submissions or functional projects and track activities, timelines & budgets, provide and communicate metrics - Providing strategic advice and proactive regulatory input to internal functions and contribute to due diligence and scientific advice - Supervision and training of Regulatory Affairs Assistances in writing submissions and maintaining regulatory databases

- Scheduling, co-ordination & preparation of dossiers (e.g. variations, renewals, marketing authorisation applications, answers to authority questions) for national, decentralised and mutual recognition procedures - Maintenance of quality related regulatory documentation in collaboration with internal functions as well as third party manufacturers - Evaluation of drug substance dossiers, change control requests - Head of eCTD working group, responsible for training of eCTD-compliant document preparation