Regulatory Affairs Associate

We are seeking a detail-oriented Regulatory Affairs Associate to join our team. The ideal candidate will play a crucial role in ensuring compliance with regulatory standards and managing documentation related to pharmaceutical products. This position requires a strong understanding of regulatory documentation processes, vendor coordination, and compliance with Good Manufacturing Practices (GMP). The Regulatory Affairs Associate will be responsible for preparing and submitting regulatory documents, including Drug Master Files (DMF) and Certificates of Analysis (CoA), while ensuring adherence to both local and international regulations, particularly in relation to Russian regulatory requirements and the Eurasian Economic Union (EAEU). Key responsibilities include collaborating with cross-functional teams to gather necessary documentation, maintaining up-to-date knowledge of regulatory changes, and assisting in audits and inspections. The successful candidate will possess excellent organizational skills, attention to detail, and the ability to work effectively in a fast-paced environment. Required skills include proficiency in regulatory documentation, vendor coordination, and a solid understanding of pharmaceutical regulations. If you are passionate about regulatory affairs and meet the qualifications, we encourage you to apply.