Обязанности:
Regulatory Affairs Manager (relocation to Cyprus) About Us FUICS is a state-of-the-art Biotech development company transforming pharmaceuticals from pre-clinical stage to commercial readiness. We are looking for a motivated individual to join us as a Regulatory Affairs Manager. The job offers great potential for personal development and growth. Job Purpose As a Regulatory Affairs Manager, you will lead and support regulatory activities for our clinical trial programs. In this role, you will be a key strategic partner to Clinical Operations, Quality, CMC and Preclinical teams, ensuring timely and compliant regulatory submissions across multiple regions. Responsibilities: Develop and execute regulatory strategies for clinical trials (Phase I–III) in alignment with global development plans. Prepare, review, and manage regulatory submissions including INDs, CTAs, amendments, and annual reports. Serve as the primary regulatory contact with health authorities (e.g., FDA, EMA, MHRA) for clinical trial matters. Provide regulatory guidance to cross-functional teams on trial design, protocols, and regulatory requirements. Track and interpret evolving regulatory guidelines and assess their impact on ongoing and planned trials. Ensure regulatory compliance throughout the clinical trial lifecycle, including inspection readiness. Contribute to internal SOPs, regulatory intelligence, and continuous process improvement initiatives. Requirements: Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or related field (advanced degree preferred). 5+ years of regulatory affairs experience in the biotechnology or pharmaceutical industry. Hands-on experience with clinical trial submissions and regulatory interactions. Strong knowledge of ICH guidelines, GCP, and global clinical regulatory requirements. Experience working with multiple regions (US, EU, and/or other international markets). Excellent written and verbal communication skills. Ability to manage multiple projects in a fast-paced, collaborative environment. Languages: English (Greek, German or Russian would be an advantage).Похожие вакансии
Менеджер по техническому регулированию (Regulatory & Scientific Affairs Manager)
Договорная
Москва
ANCOR