Regulatory Affairs Specialist
2 settimane fa
Overview Join to apply for the Regulatory Affairs Specialist (L.68/99) role at AstraZeneca Are you ready to make a difference in the world of healthcare? As a Regulatory Affairs Specialist within the Italian Marketing Company, you will play a crucial role in achieving and maintaining regulatory authorizations for new and existing products. You will support the Head of Regulatory Affairs & Medical Compliance Lead Nominated Signatory GRP Lead, ensuring compliance with local legislation and SOPs. Your work will guarantee adherence to GRP, Local and Global SOPs, MC Regulatory Process, Quality Manual, and Italian and European regulations. Accountabilities Support the Head of Regulatory Affairs & Medical Compliance Lead Nominated Signatory GRP Lead during registration applications for new products, new indications, and extensions, ensuring compliance with national and EU legislation within agreed deadlines. Guarantee the correct maintenance of registered products, including renewals, quality and safety updates, and labelling requirements, under the supervision of the Head of Regulatory Affairs & Medical Compliance Lead Nominated Signatory GRP Lead. Interact with Italian Regulatory Authorities to resolve product‑related issues, maximizing regulatory authorization effectiveness with line‑manager support if necessary. Review promotional materials from a regulatory perspective to ensure compliance with local legislation and MC Code/SOPs. Engage in competitive intelligence activities. Manage special projects (e.g., MA transfer) with support from the Head of Regulatory Affairs & Medical Compliance Lead Nominated Signatory GRP Lead. Support the Head of Regulatory Affairs & Medical Compliance Lead Nominated Signatory GRP Lead in maintaining compliance with GRP. Manage all activities and account relationships according to Company Values, Code of Conduct, Guidelines/Internal procedures, and Italian legislation. Essential Skills/Experience University Degree in Science or related discipline Good knowledge of National and EU pharmaceutical legislation Good written and verbal communication skills Good level of spoken and written English Performance‑driven Customer focus Desirable Skills/Experience Experience of working on cross‑functional teams Prior pharmaceutical industry experience At least 2 years’ experience in an area of regulatory affairs AstraZeneca offers an environment where you can be at the forefront of medical innovation. With our industry‑leading BioPharmaceuticals team, you’ll have the opportunity to make a significant impact on patients’ lives through our diverse pipeline. We are committed to evolving and accelerating our efforts in various therapeutic areas, addressing unmet needs with groundbreaking solutions. Our collaborative culture fosters growth and development, allowing you to thrive in a fast‑paced setting that values creativity and innovation. Ready to take on this exciting challenge? Apply now and become part of our dynamic team AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry‑leading skills. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non‑discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. #J-18808-Ljbffr
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Regulatory Affairs Specialist
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Via Milano, Italia AstraZeneca A tempo pienoOverview Join to apply for the Regulatory Affairs Specialist (L.68/99) role at AstraZeneca Are you ready to make a difference in the world of healthcare? As a Regulatory Affairs Specialist within the Italian Marketing Company, you will play a crucial role in achieving and maintaining regulatory authorizations for new and existing products. You will support...
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Milano, Italia Altro A tempo pienoAre you ready to make a difference in the world of healthcare?As a Regulatory Affairs Specialist within the Italian Marketing Company, you'll play a crucial role in achieving and maintaining regulatory authorizations for new and existing products.You'll support the Head of Regulatory Affairs & Medical Compliance Lead Nominated Signatory GRP Lead, ensuring...
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