Senior Regulatory Affairs Specialist

Insuvia is an outsourcing and consultancy services provider for the pharmaceutical industry. We help pharmaceutical & biotech companies make safe and effective healthcare products available worldwide by providing superior quality pharmacovigilance and regulatory affairs services.We are looking for a Senior Regulatory Affairs Specialist in Lithuania.Main ResponsibilitiesManage Regulatory Affairs related activities in Lithuania.Lead, oversee and coordinate regulatory affairs activities in other countries of scope in cooperation with colleagues based locally in those countries.Serve as the main contact point and expert for regulatory affairs for internal and external stakeholders, provide consultations and advice to customers and internal team on local regulatory requirements.Advice and support the preparation and submission of regulatory applications, including but not limited to new marketing authorization (MA) applications, variations and renewals, MA transfers, and subsequent correspondence with the regulatory authorities.Compile and/or maintain regulatory documentation databases/systems, track life-cycle submissions.Communicate with regulatory authorities regarding pre-submission strategies, potential regulatory pathways, compliance requirements, follow-up on submissions under review/evaluation.Translate/revise product information (package leaflet / summary of product characteristics).Validate artworks in line with the marketing authorization and local legislation.Review of promotional materials for regulatory compliance.Monitor regulatory duties related with assigned product portfolio.Submit national declarations and notifications to regulatory authorities as required.Perform other regulatory affairs assistance as requested.Experience, required skills and competenciesEducation in science/health discipline (e.g. Pharmacy, Medicine, Public Health or similar).Minimum of 2-year experience in in Regulatory Affairs.Fluent command of English (written and spoken).Careful planning to achieve accurate and timely results.Attention to detail.Why join usEngaging, dynamic and diverse work in a young and rapidly growing company;International and multicultural environment;A workplace where your input matters and has an impact;Broad opportunities for self-expression and professional growth;Adequate workload, work-life balance and flexibility;Modern office in the heart of Kaunas, incl. parking;