Ligia Maluf's Linkedin Analytics

Pharmacist of Regulatory Affairs Area - Regulatory strategy for start-up biotech business - Life-cycle management of Biological Products, Biosimilars, New Products, Branded Generics, APIs, and Medical Devices - Core team leader of Company’s portfolio maintenance program, together with Industrial Affairs - Price and Clinical Research dossiers - Clinical Trials projects with insulins and COVID-19 - Expertise with national and international GMP of different products categories and APIs - Support to registration in LATAM, some countries in Asia, Africa and Middle East with Regulatory Documents - Management of Processes organization, compliance to SOPs at Regulatory department, Regulatory databases development - Regulatory and Competitive Intelligence - Coordinator of GxP audits at Regulatory level - Experience in Company’s branch launch in cross-team project - Obtention and maintenance of legal sanitary documents (Operational Licences) - Import and Export activities, transport validations, products under special control - People Management