Managing all regulatory processes of MRP/DCP, CP and national procedures,MA variations, renewals, launch preparation and coordination of Product Information.Life cycle management, development and management of artwork changes,Support Quality and Logistics department, Market Access and Medical teams with up-to-date regulatory information.

• Responsibility over the Pharma and Vaccines product portfolio, primarily in terms of variation implementation (Artwork management project system)• Product repacking management to ensure having compatible stock on local market• Ensuring regulatory compliance throughout working with local authorities (Final sample/Formal defect permissions, OKI certificate, etc.)• Local translation management for variations

• Pulmonology and Diabetology product portfolio responsibilities (variations, renewals, overall maintenance)• Supporting product maintenance on the other portfolios, like diabetology, oncology, cardiology.• Working with the HU authorities, related to the above detailed product lines.• Label and manuscript management.• Audit, inspection preparations, annual regulatory budgeting, Ad-hoc projects (e.g.: product transfers)

• Coordination of packaging and manuscript development regarding new product launches and variations. • Measuring the efficiency of the implementations.• Keeping contact with supply chain management and supporting them in the stock calculation.• Translation and proofreading activities regarding new CHC and PM registrations, renewals and variations.• Local translation, checking and approval of clinical trial label texts.• Handling of product complaints.• Invoice… Show more • Coordination of packaging and manuscript development regarding new product launches and variations. • Measuring the efficiency of the implementations.• Keeping contact with supply chain management and supporting them in the stock calculation.• Translation and proofreading activities regarding new CHC and PM registrations, renewals and variations.• Local translation, checking and approval of clinical trial label texts.• Handling of product complaints.• Invoice checking, cost center delegation, ad-hoc procurement• Contributing in the regulatory budget planning.• Active participation in ad hoc audit preparation. Show less

• Facilitate the daily work at the whole regulatory department.• Active participation in the MRP/DCP submissions (EU/USA) and ad-hoc projects.• Editing submission documents / Adobe Acobat• Data management related to various projects and areas e.g. submissions, deficiency letters, etc.