Specialist Care Therapeutic Area, Global Regulatory Affairs and Patient Safety - Temporary

Job description

About us Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here. At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better. Chiesi Research & Development Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China). Who we are looking for This is what you will do We are looking for a motivated regulatory affairs professional to join our Global Regulatory and Patient Safety team on a temporary contract (maternity leave replacement). As core member of the GRT and strategic partner of the GRL, the incumbent leverages personal regulatory expertise to contribute to the definition and drive the execution of aligned global regulatory strategy. They work flexibly within and across regions (mainly Europe) to ensure the delivery of business objectives and support the development and/or execution of Global Regulatory Strategy to ensure that TPP is aligned to core product labelling for development/lifecycle management for the assigned region(s). You will be responsible for May serve as a regional/local regulatory lead and point of contact both internally and with competent national authorities in EU countries and EMA. Contribute (independently or with GRL/ Manager guidance) to the development of global HA interaction strategy in collaboration with GRT members Accountable for developing, singly or with GRL guidance/Manager support, the HA engagement & interaction plans for assigned products incl. authoring, leading & moderating preparation meetings Accountable for complete and accurate communication/interaction (including tracking in relevant systems) with the HAs, affiliates and IMDD partners for the projects/products in their remit Lead, independently or with GRL guidance, regulatory subteam to ensure NDA/BLA/ MAA/Extensions/Variations/Renewals filings meet the project timelines Collaborate with Project Manager to develop core global dossier and collaborate with other GRT members as appropriate Ensure regulatory submission timelines are aligned with program level and company objectives Contribute to content and reviews for regulated documents Support operational and compliance activities for assigned deliverables Support GMP, GCP, and GPV inspections from health authorities Accountable to provide updates on project and submissions status to GRT members Accountable to support the GRL on updates to the Affiliates and interactions with IMDD and partners You will need to have Experience in regulatory lifecycle management in Europe, particularly with MRP/DCP and centralized procedures. Fluent English Excellent attention to detail, including data consistency, traceability, and alignment across submission documents Ability to solve problems proactively and problem solving skills and the ability to work both independently and collaboratively in multidisciplinary team Fluent English We would prefer for you to have Experience with FDA Experience with biological products Location The role is based in France, with possibility to work remotely What we offer No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way. We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive. Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.