Regulatory Affairs Associate

Global Life Science Hub has partnered with a one-of-a-kind, global CDMO that specializes in providing comprehensive development and manufacturing services. With an additional 50% growth expected in Europe site, we're searching for a Regulatory Affairs Associate who will manage the relationships with key suppliers and build your own technical specialization in the animal health sector.
Responsibilities: Acquiring expertise in EU food chain regulations and applying corresponding EU/EFSA guidelines. Developing skills to draft technical dossiers and design supporting studies. Gaining experience in managing applications via the e-Submission Food Chain Platform and handling post-submission queries from EURL, EC, or EFSA. Conducting feasibility assessments, performing data audits, and maintaining up-to-date gap analyses. Drafting protocols and reviewing study reports. Performing raw data verification or statistical analyses. Coordinating with external laboratories and suppliers. Learning to register studies in the EFSA Connect Portal and submit Public Access to Documents requests. Checking the legal status of ingredients. Establishing effective communication with clients and relevant EU authorities. Supporting clients with regulatory inquiries outside the EU and following up post-delivery, focusing on upselling and budget management. Enhancing project management skills to ensure internal project management systems are current. Performing additional tasks as reasonably required within the scope of the role. Apply: If you're interested, please apply below.

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