Global Regulatory Affairs Specialist

Social network you want to login/join with: Global Regulatory Affairs Specialist, Parma col-narrow-left Client: Location: Job Category: Other - EU work permit required: Yes col-narrow-right Job Reference: 8160257735766573056337114 Job Views: 1 Posted: 08.05.2025 col-wide Job Description: Our 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 to recruit a Global Regulatory Affairs Specialist to join an exciting, dynamic, and international work environment. Purpose: The specialist is a core member of the GRT and a strategic partner of the GRL, leveraging regulatory expertise to define and execute aligned EU, extra-EU, and global regulatory strategies, working flexibly across regions to meet business objectives. Supports the development and execution of the global regulatory strategy to support the TPP. Ensures alignment of TPP with core product labelling for development and lifecycle management in 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 HA interaction strategies, with or without GRL guidance. Develop, lead, and moderate health authority engagement and interaction plans, including authoring and preparing meetings. Maintain complete and accurate communication with relevant HAs, including tracking interactions. Lead regulatory sub-teams to ensure timely NDA/MAA/Extensions/Variations filings, develop core dossiers, and collaborate with GRT members. Align regulatory submission timelines with program and company goals. Contribute to content and review of regulated documents. Support operational and compliance activities for deliverables and HA contact reports (EU & extra-EU). Assist with GMP, GCP, and GPV inspections by health authorities. Provide updates on project and submission statuses at GRT meetings. Support the GRL with updates to affiliates and interactions with IMDD and partners. Experience Required: Approximately 3 years of experience in Regulatory Affairs. Education: [Details Needed] Languages: [Details Needed] Technical Skills: 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, work experience, and studies. Applications without the required qualifications will not be fully considered. Please provide authorization for data processing under GDPR regulations. This research is urgent and open to candidates of all genders (L.903/77). J-18808-Ljbffr

Location: parma, IT

Posted Date: 5/11/2025