Global Regulatory Affairs Specialist

Social network you want to login/join with: Global Regulatory Affairs Specialist, Teramo Job details: Client: Chiesi Farmaceutici Location: Teramo Job Category: Other EU work permit required: Yes Job Reference: 8160257735766573056337168 Job Views: 1 Posted: 08.05.2025 Job Description: Our client, Chiesi Farmaceutici —one of the top 50 pharmaceutical companies worldwide, with over 80 years of experience in the pharmaceutical and biotech industries—seeks to expand their team. IQVIA is recruiting a Global Regulatory Affairs Specialist to join a 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. Support development and execution of global regulatory strategies for the TPP and ensure alignment of TPP with core product labeling for development and lifecycle management. Main Responsibilities: Serve as a regional/local regulatory lead and point of contact internally and with health authorities. Contribute to global HA interaction strategies in collaboration with GRT. Develop health authority engagement and interaction plans, including authoring and moderating meetings. Maintain accurate communication and tracking with relevant HAs. Lead or support regulatory sub-teams to ensure timely NDA/MAA/Extensions/Variations filings, develop core dossiers, and collaborate with GRT members. Ensure submission timelines align with program and company goals. Review and contribute to regulated documents. Support operational and compliance activities, including HA contact reports (EU & extra-EU). 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 Required: Approximately 3 years in Regulatory Affairs. Skills and Qualifications: Understanding of clinical development of drugs and biologics. Knowledge of lifecycle management activities in EU and major extra-EU countries. Experience with electronic document management systems like Veeva Vault. Ability to handle 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 lacking the required qualifications will not be fully considered. Please provide consent for data processing as per GDPR regulations. This recruitment is open to candidates of all genders (L.903/77). J-18808-Ljbffr

Location: teramo, IT

Posted Date: 6/17/2025