Manager, ORSSE Labeling

Job title:

Manager, ORSSE Labeling

Company:

AstraZeneca

Job description

Are you ready to take on a role that prepares and executes global/regional regulatory tactical submission plans on allocated projects/products? This role is designed for individuals who are ready to implement the agreed regulatory strategy to develop and maintain products. As a Manager, ORSSE Labeling, you will generate and project manage the delivery of submissions, ensuring they meet time and quality standards. This role is perfect for those who have in-depth knowledge of Regulatory compliances and submissions, and are ready to build good relationships with internal customers and Regulatory authorities.Accountabilities:Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs.Provide support to the Labeling Strategist with regards to labeling documents for submissionProvide guidance to labeling teams regarding regulatory technical requirements for regional labeling submissionsManage labeling submissions for US and EU, including QC, proofing, copy editing and formatting of documents, and coordinate review and approval of final submission documentsUnderstand industry labeling trends related to labeling and submission guidance and directivesInterpret regional labeling regulations and guidance, determining company impact and providing comments as appropriateLiase with Labeling Strategy and RAM to advise/recommend submission best practicesContribute the regulatory labeling perspective in support of submission deliveryAt the request of Labeling Strategist, originate precedent searches, create and maintain labeling comparisonsInteract with Marketing Company colleagues regarding linguistic review and translationsOversee and coordinate EU linguistic review process as appropriateInteract with appropriate functional groups to obtain labeling annotations and supporting documentationAuthor Content of Labeling/Drug Listing SPL fileGenerate and validate SPL file for submissionDraft summaries of relevant labeling changes for PSURs, Annual Reports and other periodic reportsMaintain labeling lifecycle of documents and ensure proper naming according to DNCCoordinate with Regional Regulatory staff to deliver submission ready documents and ensure submission timelines are metAssist in responding to labeling-related queries from various functional areasAssist Global Labeling team in resolution of labeling issues as neededParticipate in the development and maintenance of work practices, templates, and associated documents relating to the labeling functionLiaise with senior management as needed to resolve critical labeling issuesRepresent functional expertise at relevant department meetings and relevant cross functional subteamsEssential Skills/Experience:University Degree in Science or related discipline3 to 5 years of labeling experienceRegulatory or labeling strategy experience (developing the labeling words for the core data labeling and EU labeling)Knowledge of labeling regulations and guidancesKeen attention to detail and accuracyExcellent verbal and written English communication skillsMulti-cultural awareness and sensitivity; demonstrated experience effectively communicating and negotiating in diverse cultures.Ability to think strategically, appropriately assess risks and formulate strategies to manage risk

Must demonstrate competencies in: Building Relationships, Negotiation Skills, Critical Information Seeking, Rational Persuasion, Interpersonal AwarenessWhen we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.Why AstraZeneca?At AstraZeneca’s Oncology R&D department, we bring hope and solutions to patients with unmet needs across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible. We are all compassionate team players and driven achievers, always ready to step up. We’re motivated by science, success and achieving our goals in a way that’s novel and thoughtful.Are you ready to turn our pipeline into reality to impact unmet patient needs? Our rich and robust pipeline provides the opportunity to work with a variety of ground-breaking medicines across diverse therapy areas and at all stages of the development process. We work to bring medicines to patients as efficiently and effectively as possible to ultimately address unmet needs across the globe.Ready to make a difference?Apply now and join us in our mission to bring life-changing medicines to people.*Please apply with an English resumeDate Posted 28-may-2024Closing Date 17-jun-2024AstraZeneca 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.

Expected salary

Location

Barcelona

Job date

Thu, 30 May 2024 05:44:26 GMT

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