Regulatory Affairs Manager (m/f/d) palleos healthcare is an international full-service CRO focused on Central and Eastern Europe. We offer clients in the pharmaceutical industry and biotech companies a wide range of services with a high level of medical expertise. Our expertise ranges from conducting clinical trials to advising on development plans and the market launch of innovative medical products and drugs. Role Description This is a full-time role for a Regulatory Affairs Manager. The Regulatory Affairs Manager will be responsible for ensuring compliance with regulatory requirements, managing regulatory submissions, and maintaining quality systems. Ensuring compliance with relevant laws, regulations, and guidelines related to clinical research activities. • Developing and implementing policies and procedures to ensure regulatory compliance. • Providing regulatory guidance and support to project teams, including reviewing study protocols, informed consent forms, and regulatory submissions. • Regulatory Compliance and Regulatory Affairs skills • Understanding of Regulatory Requirements • Experience in managing Regulatory Submissions • Knowledge of Quality System management • Strong analytical and problem-solving skills • Excellent attention to detail and organizational skills • Effective communication skills and ability to work in a team • Bachelor's or Master's degree in Regulatory Affairs, Life Sciences, or related field We offer: • Further training opportunities in AMG / ICH GCP, MPDG / ISO 14155 and GAMP 5 • Structured onboarding by our competent and friendly employees • Alternating home office • Professional support for your personal and professional development in our company • An open and fast-moving organization • A crew of team players To become part of the palleos healthcare team, apply now and send us your informative application documents summarized in a PDF file and the reference number YF-18198 by e-mail to bewerbung[AT]palleos.