PstrongJOB DESCRIPTION: /strong /ppResponsible for supporting global regulatory submissions and maintaining compliance with regulatory requirements for pharmaceutical products across multiple regions aligned with global regulatory strategies. This role involves preparing regulatory dossiers, coordinating with health authorities, ensuring product registration, and providing regulatory guidance to cross-functional teams. /ppbr/ppstrongRESPONSABILITIES: /strong /ppbr/ppstrongemRegulatory Submissions Documentation /em /strong /pulliPrepare, compile, revise, and submit global regulatory dossiers for new Marketing Authorization Applications (MAAs), variations, renewals, and lifecycle management activities. /liliCollaborate in the preparation and/or revision of global regulatory submissions to ensure completeness, accuracy, alignment with company objectives, and compliance with the latest local and international regulations. /liliPrepare documentation and submissions to Health Authorities, either directly or through local partners, ensuring regulatory compliance and supporting efficient product registration and maintenance. /liliSupport labelling and change control processes to ensure timely and comprehensive review and approval of packaging components (cartons, labels, Physician Insert, Patient Insert, Medication Guides). /liliManage other legal documentation required for registrations, such as Certificates of Pharmaceutical Product (CPPs). /liliMaintain accurate and up-to-date regulatory documentation and regulatory files in accordance with global standards. /liliInput regulatory intelligence, requirements, and submission data into relevant regulatory systems/databases, ensuring data accuracy and consistency. /li /ulpbr/ppstrongemRegulatory Compliance, Strategy Lifecycle Management /em /strong /pulliSupport the implementation of global regulatory strategies for assigned products to achieve regulatory approvals and maintain compliance throughout the product lifecycle. /liliAdvise and collaborate with cross-functional teams (RD, QA, Manufacturing, etc.) on regulatory requirements to ensure successful market approval and lifecycle management. /liliContribute to regulatory intelligence activities and provide insights into the evolving global regulatory landscape. /li /ulpbr/ppstrongemRegulatory Operations /em /strong /pulliContribute to the creation, maintenance, and improvement of the Regulatory Affairs Quality System, collaborating on the definition of processes and the implementation of global standard procedures. /liliMaintain high-quality regulatory documentation and ensure compliance with procedural, regulatory, and system requirements across regions. /liliAdministrative and internal systems management (iPARTS, DACRA and any other tool). /li /ulpbr/ppstrongemKnowledge /em /strong /pulliGood knowledge of EMA, ICH, regulations and guidelines related to drug development, approval, and lifecycle management. /liliGood knowledge of Extra EU countries’ regulation is preferred. /liliStrong organizational skills with the ability to handle multiple regulatory projects simultaneously and manage multiple stakeholders. /liliGood commercial and product awareness. /liliStrong administrative and systems background, including experience with regulatory databases and document management tools. /li /ulpbr/ppstrongemPosition Impact /em /strong /pulliSimultaneous management of multiple global regulatory projects with several internal and external stakeholders. /liliHigh impact on regulatory compliance and ensuring product availability in the market. /li /ulpbr/ppbr/ppstrongMINIMUM REQUIREMENTS: /strong /ppbr/pulliMinimum 3 years of experience in Regulatory roles within the Pharmaceutical Industry. /liliGood knowledge of EMA and ICH regulations, guidelines, and regulatory processes regarding drug development, approval, and maintenance of marketing authorizations. /liliGood knowledge of Extra EU countries’ regulation is preferred. /liliFamiliarity with eCTD submission, compilation, and publishing using specific tools. /liliGood commercial and product awareness. /liliSound administrative and systems background. /liliAbility to develop good cross-functional working relationships and tactical coordination of projects. /liliFluent in English, spoken and written is a must. /li /ul