Requirements: English
Company: JR Italy
Region: Pavia , Lombardia
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 staff. IQVIA is recruiting a Global Regulatory Affairs Specialist to join an exciting, dynamic, and international environment.Purpose:This role involves leveraging regulatory expertise to contribute to the development and execution of global regulatory strategies across regions, supporting business objectives, and ensuring alignment of product labeling and lifecycle management.Main Responsibilities:Serve as a regional regulatory lead and contact point with Health Authorities.Develop and implement health authority interaction strategies and engagement plans.Lead regulatory submissions, including NDAs, MAAs, and variations, ensuring timely delivery and collaboration within the global team.Maintain accurate communication and tracking with health authorities.Support operational and compliance activities, including inspections and updates at GRT meetings.Experience Required:Approximately 3 years in Regulatory Affairs.Technical Skills:Understanding of clinical drug development 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 manage multiple projects and work in multicultural environments.Soft Skills:Stress and time management.Planning, organizational, and strategic thinking skills.We Offer:Competitive salary packagePermanent contractChemical contractNote: EU work permit is required. Applications must meet the specified requirements; otherwise, they will not be fully considered. Consent for data processing according to GDPR is required. The position is open to candidates of all genders.#J-18808-Ljbffr