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.