Regulatory Affairs Consultant - CMC biologics (home or office based)

This a Full Remote job, the offer is available from: Hungary, Poland, Romania, Spain, Czechia, Italy, Croatia, Serbia, Oregon (USA) When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Are you an experienced regulatory affairs professional looking for a new opportunity? We are currently seeking a talented Regulatory Affairs Consultant to join our dynamic team! This is a client dedicated project, and the role can be office or home based in various European locations. As the Regulatory Affairs Consultant you will play a vital role in our company's worldwide post-approval regulatory activities, specifically focused on Chemistry, Manufacturing, and Controls (CMC) for biological products. Primary Tasks & Responsibilities: • Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports. • Assess change controls and provide regulatory assessments of quality changes in production and quality control. • Review study reports from the quality control and production departments to ensure compliance with regulatory requirements. • Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies. • Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities. • Manage projects within all 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 related to technical/CMC/quality, within 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 processes. • Background in validation/Quality Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation. Understanding of qualification/validation principles. • Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued. • Team spirit, flexibility, accountability, and organizational skills. • Fluent in English (written and spoken). This offer from "Parexel" has been enriched by Jobgether.com and got a 86% flex score. Apply tot his job Apply To this Job