IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics, and human ingenuity to drive healthcare forward. **Regulatory Affairs Specialist – EU & Global Markets (remote / hybrid)** **Language:** Fluent English required Join our dynamic Lifecycle Management team as a **Regulatory Affairs Specialist** **(2 separate positions: L** **ifecycle Management role and CMC role)** supporting post-approval regulatory activities for **human medicinal products** across the EU and global markets. This is an individual contributor role ideal for professionals with at least 4 years of experience in EU regulatory affairs. **Key Responsibilities** + **Lifecycle management role:** collaborate with local teams to prepare and submit regulatory documents (notifications, renewals, variations, new applications, MAH transfers) to local Health Authorities. + **CMC role:** Draft high-quality regulatory and module 3 documentation with minimal supervision. Experience in technical writing. Regulatory impact assessment of proposed CMC variations according to EU regulations. + Support the regulatory approval process and ensure compliance with local and international requirements. + Build and maintain strong relationships with internal stakeholders and external partners. + Participate in meetings with our clients - global pharmaceutical companies. + Communicate with Regulatory Agencies. **Qualifications** + Bachelor’s or Master’s degree in Life Sciences or related field. + Minimum 4 years of experience in post-approval regulatory affairs for the EU market. + **Lifecycle management role:** solid understanding of EU regulatory guidelines. Experience in submissions of new marketing authorizations, variations, renewals. + **CMC role:** experience in categorization proposed variations according to EU guidelines from medicinal products. Experience in production/ R&D/ quality environment in a pharmaceutical company is a must. + Fluent in English (C1 or above). + Strong organizational and time management skills. + Proficiency in Microsoft Office. + Ability to work independently and adapt in a fast-paced environment. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled