Senior Regulatory Affairs Officer Introduction to role
Within the Italian Marketing Company, you will achieve and maintain regulatory authorizations for new and existing products in compliance with local legislation and Marketing Company Code/Standard Operating Procedures (SOPs). You will ensure the maintenance and compliance to GRP, GMP, Local and Global SOPs, MC Regulatory Process, and Quality Manual of the Italian Marketing Company, as well as Italian and European regulations and legislations.
Accountabilities
Manage the registration application for new products, new indications, and extensions, in compliance with up-to-date national and EU legislation and within the agreed deadlines. Guarantee the correct maintenance of registered products (renewals, quality and safety updates, labelling requirements, and implementation). Interact with Italian Regulatory Authorities to resolve any product-related issues (including shortages) to maximize the effectiveness of regulatory authorization with the support of the Line Manager, if necessary. Ensure compliance to GRP with specific responsibilities including supervising regulatory knowledge traceability, proper archiving of relevant documents related to regulatory activities, and ensuring that Global SOPs and guidance are adopted in local SOPs. Participate in Issue Management Teams (IMTs) and recall management activities as a back-up of the Local Recall Administrator. Manage communications with Regulatory Authorities following actions determined by the central Issue Management Team, which may include market action. Scope includes all products distributed within Italy. Review promotional materials from a regulatory perspective to ensure compliance with local legislation and MC Code/SOPs. Actively participate in business product teams and local/international meetings. Estimate the Time to Market (TTM) for AZ products and competitors. Support Market Access and Marketing for P&R dossier. Manage special projects like MA transfer with the support of the Line Manager, if necessary. Manage other regulatory associates for the above-mentioned activities. Essential Skills/Experience
University Degree in Science or related discipline Good knowledge of National and EU pharmaceutical legislation Experience in an area of regulatory affairs Experience of working on cross-functional teams Desirable Skills/Experience
Master's degree or equivalent in science/healthcare related field Prior pharmaceutical industry experience Experience at a healthcare authority At AstraZeneca, we are at the forefront of shaping the future of healthcare. Our unique position as medical leaders allows us to drive meaningful change through partnerships with external experts, policy makers, and patient groups. We thrive on innovation and collaboration, working across different markets and functions to deliver science to patients in need. Our dynamic environment offers endless opportunities for growth and development, making a significant impact on patients' lives.
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