Global Regulatory Affairs Specialist

10 ore fa

Bardi, Italia Jefferson Wells Italia A tempo pieno

Overview SCOPO DEL RUOLO: Responsible for supporting global regulatory submissions and maintaining compliance with regulatory requirements for pharmaceutical products across multiple regions aligned with global regulatory strategies, with particular reference to EU. This role involves preparing regulatory dossiers, coordinating with health authorities, ensuring product registration, and providing regulatory guidance to cross-functional teams. Responsibilities Regulatory Submissions & Documentation Prepare, compile, and submit global regulatory dossiers for new marketing authorisation applications (MAA s), variations, renewals. Ensure timely and accurate submission of documents in compliance with global regulations. Support the labeling and change control processes to ensure timely and comprehensive review and approval (e.g., Labels, Physicians Insert, Patient Insert, and Medical Guides). Maintain high-quality regulatory documentation, ensuring it is consistent, accurate, and compliant with regulatory requirements in different regions. Regulatory Compliance & Strategy Support the development and implementation of global regulatory strategies for assigned products in collaboration with internal teams to ensure products. Monitor regulatory changes and industry trends to ensure compliance with evolving guidelines and support the updating of regulatory strategies. Advise cross-functional teams (R&D, Quality Assurance, Manufacturing, etc.) on regulatory requirements and strategies for market approval/lifecycle management. Contributes to the creation and maintenance of the Regulatory Affairs quality system, collaborating to define processes and implementation of global standard procedures. Maintain knowledge of global regulatory requirements and trends, sharing relevant updates with internal teams. Contribute to regulatory intelligence activities and provide insights into global regulatory landscape developments. Track regulatory submissions, approvals, and regulatory activities using tracking systems and ensure timely reporting to management. Requirements Experience & Knowledge• Good knowledge of EMA, ICH and FDA regulations, guidelines, and regulatory processes regarding drug development, approval, and maintenance of marketing authorisationions. Skills• Strong organisational skills • Good commercial and product awareness • Sound administrative and systems background. Experience• Minimum 3 years of experience in Regulatory Affairs in the Pharmaceutical Industry. Education• Master Degree in scientific subject, preferably in Pharmacy or related. Master in Regulatory Affairs is considered a plus. Languages• Fluent in English, spoken and written. Tools• Master of Office Systems• Familiarity with e CTD submission, compilation and publishing using specific tools.#J-*****-Ljbffr

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