Global Regulatory Affairs Specialist

Global Regulatory Affairs Specialist, Savona Our client, Chiesi Farmaceutici – one of the top 50 pharmaceutical companies worldwide with over 80 years of experience in the pharmaceutical and biotechnology industry – is expanding their team. IQVIA is recruiting a Global Regulatory Affairs Specialist to join an dynamic, international environment. Purpose: As a core member of the GRT and strategic partner of the GRL, leverage regulatory expertise to define and execute aligned EU, extra-EU, and global regulatory strategies, working flexibly across regions to meet business objectives. Main Responsibilities: Serve as a regional/local regulatory lead and point of contact with Health Authorities. Contribute to global HA interaction strategies in collaboration with GRT. Develop and manage health authority engagement and interaction plans, including authoring and leading meetings. Ensure accurate communication with relevant HAs and track interactions. Lead regulatory sub-teams to meet submission timelines, develop dossiers, and collaborate with GRT members. Align regulatory submission timelines with project and company goals. Contribute to and review regulated documents. Support operational and compliance activities, including HA contact reports. Assist with GMP, GCP, and GPV inspections. Provide updates on project and submission statuses at GRT meetings. Support updates to affiliates and interactions with IMDD and partners. Experience Required: 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 such as Veeva Vault. Ability to manage multiple projects simultaneously. Sensitivity to multicultural/multinational environments. Soft Skills: Stress management 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, and relevant experience. Applications without the required qualifications will not be fully considered. Consent to personal data processing is required, in accordance with GDPR. The recruitment is urgent and open to candidates of all genders. J-18808-Ljbffr

Location: savona, IT

Posted Date: 5/11/2025