OverviewAzurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.PositionManager, Regulatory Affairs: Managing EU and International Regulatory activities for assigned projectsResponsibilitiesManage and coordinate regulatory submissions for all projects to include but not limited to Scientific Advice, Pediatric Implementation Plan submissions, MAAs, variations and other associated life cycle maintenances submissions.Develop and implement regulatory strategies for product registration and life cycleLead cross-functional discussions to align on submission strategies, prioritize activities, and establish realistic implementation timelines for regulatory activities based on the cross-functional requirements.Review labelling (SPC, PIL and Labelling) to ensure compliance against current guidelines and standardsReview change controls for the regulatory teamOwnership of all outside communication with EU/EEA Health Authorities (EMA, National Competent Authorities) on behalf of the CompanyProvide guidance to support with regulatory related questions and complaintsMonitor evolving regulatory requirements and provide proactive advice to cross functional teamsFollow company policies and proceduresContribute to generate and review SOPs and Work instructionsPeriodically reviewing the product information (SPC, PIL and Labelling) for compliance against the Core Safety Information (CSI) as well as current EU guidelines and standardsManage the artwork preparation and approval process of printed packaging components to meet packaging design and legislation requirements for each new product, new packs, or changes to existing packagingManaging publishing and translation activities with support from partner CROSupport review of EU promotional materialQualifications and Education RequirementsBachelor of Science, Biological Sciences or other related area of study5-7+ years of experience in Regulatory Affairs especially with European, UK exposureRegulatory Affairs exposure to China would be considered a plusProven experience with EMA, NCA’sStrong background in pre-marketing activities and preparation of MAA’sAbility to perform under pressure with limited resourcesExcellent communication and presentation skills in EnglishStrong writing analytical and problem-solving abilities
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