Global Regulatory Affairs Specialist

Our client, Chiesi Farmaceutici – one of the top 50 pharmaceutical companies in the world, with more than 80 years of experience in the pharmaceutical and biotechnology industry – is seeking to expand their team. They have entrusted IQVIA with the recruitment of a Global Regulatory Affairs Specialist to join an exciting, dynamic, and international work environment. Purpose As a core member of the GRT and a strategic partner of the GRL, leverage your regulatory expertise to contribute to the development and execution of aligned EU, extra-EU, and/or global regulatory strategies. Work flexibly across regions to ensure the achievement of business objectives. Support the development and execution of global regulatory strategies to support the TPP. Ensure alignment of TPP with core product labelling for development and lifecycle management within assigned regions. Main Responsibilities Serve as a regional/local regulatory lead and point of contact internally and with health authorities. Contribute to the development of global health authority interaction strategies in collaboration with the GRT. Develop and manage health authority engagement and interaction plans, including authoring, leading, and moderating preparation meetings. Maintain complete and accurate communication with relevant health authorities, including tracking interactions. Lead regulatory sub-teams to ensure NDA/MAA/extensions/variations filings meet project timelines and collaborate with GRT members. Align regulatory submission timelines with program and company objectives. Review and contribute to regulated documents. Support operational and compliance activities, including HA contact reports for EU and extra-EU regions. Assist with GMP, GCP, and GPV inspections by health authorities. Provide updates on project and submission status at GRT meetings. Support the GRL with updates to affiliates and interactions with IMDD and partners. Experience and Education Approximately 3 years of experience in Regulatory Affairs. Master's degree required. Fluent in English. Technical Skills Understanding of clinical drug development and biologics. Knowledge of lifecycle management activities in EU and major extra-EU countries. Proficiency with electronic document management systems like Veeva Vault. Ability to handle multiple projects simultaneously. Sensitivity to multicultural environments. Data readiness and competitive intelligence skills. Soft Skills Teamwork, stress management, time management, planning, and organizational skills. Strategic thinking. What We Offer Competitive salary package. Permanent contract. Chemical contract. IQVIA reserves the right to evaluate candidates with domicile/residence and work experience/study that meet the requirements. Applications without the required qualifications will not be fully considered. Please provide authorization for data processing under GDPR (DL196/2003 and GDPR 679/2016). This is an urgent search for candidates of both sexes (L.903/77). J-18808-Ljbffr

Location: veneto, IT

Posted Date: 6/6/2025