Who we are looking forPurposeJoin regulatory affairs in Rare Diseases Area!
Be part of a dynamic, impactful field where every decision brings life-changing therapies closer to patients in needMain ResponsibilitiesUnder guidance of the regional Head, prepares, compiles, and maintains regulatory documents to support a broad range of submissions to regional regulatory authorities within a given timeline.
In collaboration with consultants, partners and affiliates, plans, coordinates, and manages regulatory submissions to regional agencies throughout the life cycle of Global Rare Disease products.
Critically review regulatory submission documents, periodic updates, overviews, summaries, etc., makes recommendations for improvement and ensures adequacy for submission.
Contributes to the development of processes and the preparation of Standard Operating Documents for Global Rare Disease RA.
Upon request of the manager, provides regulatory guidance to colleagues from other functional areas.
Prepares responses to questions and/or information requests from regulatory agencies within the timeframes specified.
Liaises with internal customers, and external customers (e.g., staff at the contract manufacturing organizations, partners, affiliates, and contract research organizations) to request and obtain data relevant to submissions.
Uses data management systems to track regulatory information pertaining to planned activities and life-cycle management of products.
Experience RequiredAt least 2 years of experience in regulatory affairs in EU and/or INT at corporate level in a multinational companyEducationScientific DegreeLanguagesFluent EnglishTechnical SkillsExperience and knowledge in the life cycle management of regulatory filing.
Ability to work under supervision in the preparation of high-quality submissions and submission documents.
Strong attention to details and quality of documents and processes.
Good knowledge of the basic Office programsSoft SkillsAdaptability and flexibilityCommunication skillsDecision makingLearning agilityPlanning and organizational skillsLocationPlease consider that the position is open to candidates based anywhere in EuropeWhat we offerYou would join a dynamic, fast-growing, challenging and friendly environment.In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development.
Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best.
That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.