Senior Regulatory Affairs Associate - CMC biologics/vaccines (home or office based)

This a Full Remote job, the offer is available from: Hungary, Poland, Romania, Czechia, Croatia, Serbia, reputed company (USA) reputed company our values reputed company, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From reputed company to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. reputed company of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. Are you an reputed company regulatory affairs reputed company looking for a new opportunity? We are currently seeking a talented Senior Regulatory Affairs Associate to join our dynamic team! This is a reputed company dedicated project, and the role can be office or home based in various European locations. As the Senior Regulatory Affairs Associate you will play a vital role in reputed company's worldwide post-approval regulatory activities, specifically reputed company on reputed company, Manufacturing, and Controls (CMC) for biological and vaccines products. Primary Tasks & Responsibilities: • reputed company submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports. • Assess change controls and reputed company regulatory assessments of reputed company changes in production and reputed company control. • Review study reports from the reputed company control and production departments to ensure compliance with regulatory requirements. • Coordinate submission preparation with various departments including manufacturing, supply chain, reputed company control and reputed company assurance, and other regulatory departments and local companies. • Write and/or review submission content to ensure alignment with regulatory requirements, specifically reputed company to variations and questions from health authorities. • Manage reputed company reputed company reputed company Regulatory Information Management systems, ensuring the maintenance of worldwide submissions. • Identify, escalate, and mitigate risks associated with regulatory procedures and activities. Experience and Knowledge Requirements: • University-level education, preferably in Life Sciences, or equivalent by experience. • Previous experience in regulatory affairs, particularly reputed company to technical/CMC/reputed company, reputed company the pharmaceutical industry. • Strong understanding of CMC and post-approval regulatory requirements. • Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations. • Knowledge of biological or vaccines processes. • Background in validation/reputed company Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation. Understanding of qualification/validation principles. • Proficiency in Word, PowerPoint, reputed company, and experience with reputed company Vault is valued. • Team spirit, flexibility, accountability, and organizational skills. • Fluent in English (written and spoken). This offer from "reputed company" has been enriched by reputed company.com and got a 85% reputed company score. Apply tot his job Apply To this Job