GVP Auditor 1

Profile: Eighteen years of Regulatory Affairs experience and twelve years with Pharmacovigilance. o Responsible for the implementation of the Regulatory Affairs department and the Pharmacovigilance center in the Pharmaceutical Industry. o Experience with Pharmacovigilance Audit representing CRQA firm based in India (Clinical Regulatory Quality Assurance) for Multinational Companies. o Experience with Pharmacovigilance Auditing in third parties, in companies whose product´s marketing authorization were acquired by Medquimica (belonging to the Lupin Group). o I faced two international audits from Lupin India, in addition to the annual self-inspections and inspections received by third parties who acquired licenses for some of the company's products through negotiation (contract). o Vast experience with medicines – generics, brand generics, OTC products, herbal medicines, and innovative products; o Responsible for Cosmetic Registration and review of advertising material as well as participation in the packaging materials development; o Experience with GMP inspections for medicines, based on Brazilian requirements (part of the Global Corporative Audit Team, focusing on the preparation of international manufacturing sites for ANVISA´s GMP inspections); o Experience with provide ANVISA´s certificate for Foreign CROs; o Strong interpersonal, communication, influencing and negotiation skills; o Strong knowledge of regulatory affairs and understands its role in the drug development/approval/life cycle process eg: clinical trials support, preparation of marketing authorizations, life cycle management, regulatory intelligence; o Strong organizational skills with ability to set priorities and meet deadlines and priorities; o Experience in conducting technical and strategic meetings with regulatory agencies and class institutions. Languages known: Portuguese- native, English – advanced level. Based in Brazil. International Experience in INDIA – Pharmacovigilance Global Conference with all Lupin Pharmaceutical Group subsidiaries, CHILE – Leisure trip.