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 vaccines or 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, escalat,e 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 vaccines or biological processe