Global Regulatory Affairs Specialist, TrentoOur client, Chiesi Farmaceutici – one of the top 50 pharmaceutical companies in the world, with over 80 years of experience in the pharmaceutical and biotechnology industry – is expanding its team. IQVIA has been entrusted with recruiting 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 regulatory expertise to contribute to the definition and execution of aligned EU, extra-EU, and/or global regulatory strategies. Work flexibly across regions to ensure the achievement of business objectives. Support development and execution of global regulatory strategies to support the TPP, and ensure alignment of TPP with core product labelling for development and lifecycle management.Main Responsibilities:Serve as regional/local regulatory lead and point of contact internally and with health authorities.Contribute to the development of global health authority interaction strategies.Develop and manage health authority engagement and interaction plans, including authoring and leading meetings.Maintain accurate communication and tracking with relevant health authorities.Lead regulatory sub-teams to ensure timely NDA/MAA submissions and collaborate with GRT members.Ensure regulatory submission timelines align with program and company objectives.Review and contribute to regulated documents.Support operational and compliance activities, including health authority contact reports.Assist with GMP, GCP, and GPV inspections.Provide project and submission updates at GRT meetings.Support updates to affiliates and interactions with IMDD and partners.Experience and Education:Approximately 3 years of experience in Regulatory Affairs.Technical Skills:Understanding of clinical development and biologics products.Knowledge of lifecycle management activities in EU and major extra-EU countries.Proficiency with electronic document management systems like Veeva Vault.Ability to manage multiple projects simultaneously.Sensitivity to multicultural/multinational environments.Soft Skills:Stress and time management.Planning and organizational skills.Strategic thinking.We Offer:Competitive salary package.Permanent contract.Chemical contract.IQVIA reserves the right to evaluate candidates based on domicile, residence, work experience, and studies aligning with the requirements. Applications lacking these requirements will not be fully considered. Please provide authorization for data processing in accordance with GDPR (DL196/2003, 13 GDPR 679/16). This research is urgent and open to candidates of all genders (L.903/77).
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