Prepare and deliver the registration applications of new products, new indications/formulations and license maintenance applications throughout the product’s life cycle of new products, as well as the follow-up and its approval ensuring a correct application instruction and compliance with deliver and approval deadlines. Update database information related to regulatory activity at local and international level to ensure portfolio information, contribute to documentation management, provide data on business management, such as benchmarking, launches, etc. Interact with the European Regulatory Affairs Group and Regulatory Authorities to ensure the local implementation of international projects. Review promotional materials aiming ensuring compliance with relevant legislation, internal procedures and any other applicable legal requirements.Cooperate in the preparation/review SOPs and OPIs in the scope of Regulatory Compliance. Cooperate with Technical Direction ensuring regulatory compliance. Coordination of the review and approval of the artworks of printed materials, ensuring its compliance with AstraZeneca standards (Packaging Manual & Global Pack Branding Booklet) and implementation with the required deadlines. Technical support in the area of intellectual property protection, patents and brands.

Prepare and deliver the registration applications of new products, new indications/formulations and license maintenance applications throughout the product’s life cycle of new products, as well as the follow-up and its approval ensuring a correct application instruction and compliance with deliver and approval deadlines. Update database information related to regulatory activity at local and international level to ensure portfolio information, contribute to documentation management, provide data on business management, such as benchmarking, launches, etc. Interact with the European Regulatory Affairs Group and Regulatory Authorities to ensure the local implementation of international projects. Coordinate the review of texts to include in the technical publications according to commercial objectives and ensuring compliance with the relevant legislationCooperate in the preparation/review SOPs and OPIs in the scope of Regulatory Compliance. Cooperate with Technical Direction ensuring regulatory compliance. Participate as a member of Product Teams and other cross-functional teams. Coordination of the review and approval of the artworks of printed materials, ensuring its compliance with AstraZeneca standards (Packaging Manual & Global Pack Branding Booklet) and implementation with the required deadlines.

Personal Assistant Support to Regulatory & Government Affairs Director with regards to administrative specific objectives. Responsible for processing and handling confidential personnel matters on behalf of the Regulatory & Government Affairs Director. Assistance to budget administration and monitoring. Manage the logistical arrangements for internal/external meetings/ conferences /workshops and manage diary Schedules. Keep updated on relevant administrative systems and policies to be able to give assistance regarding e.g. purchasing, invoices. Technical support in the area of intellectual property protection, patents and brands.