Regulatory Specialist/Executive

Details of the offer

Join a place built on innovation and creativity. Where different views and perspectives are welcomed and valued. An environment that champions inclusion, and teams that reflect the diversity of the communities that we serve.
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies.
At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.
QUALIFICATIONS University degree from reputable universities (Preferably from Pharmacy, Chemistry, Chemical Engineering, Biology departments)Advanced command of written and spoken EnglishPreferably regulatory work experience in a pharmaceutical company:Min 1 year of Regulatory Affairs experience for Specialist positionMin 4 years of Regulatory Affairs experience for Executive positionAdvanced knowledge in MS Office applicationsHigh interpersonal, communication and presentation skillsGood at teamworkGood at follow-up and strong planning skillsNo restriction for travelNo military obligation for male candidatesJOB DESCRIPTION Preparation of registration and variation files according to current Ministry of Health requirementsApproval of registrations and sales permissionsPreparation of SmPC/PIL submissionsManage the written correspondence with Ministry of Health before and after registration approvalFollow up global and local regulatory requirementsMaintain and update global and local regulatory systemsDate Posted: 23-Sub-2024 Closing Date: Global Career Level: D 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 believe that the more inclusive we are, the better our work will be. 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.

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