- Submission of new marketing applications for medicinal products and maintenance of theMarketing authorisations already granted (quality and safety variations and renewalapplications);- Submission/notification for non-medicinal products: medical devices, food supplements andcosmetics;- Looking for new products in order to increase the company´s portfolio;- Development of new products for company (food supplements);- Implementation of Ferraz Lynce’s Quality… Show more - Submission of new marketing applications for medicinal products and maintenance of theMarketing authorisations already granted (quality and safety variations and renewalapplications);- Submission/notification for non-medicinal products: medical devices, food supplements andcosmetics;- Looking for new products in order to increase the company´s portfolio;- Development of new products for company (food supplements);- Implementation of Ferraz Lynce’s Quality System;- Responsible for Ferraz Lynce’s Pharmacovigilance System;- Research of published articles in literature/database, requested by health care professionals;- Scientific information/clarification to healthcare professionals and patients;- Sales representative training (pharmacological, pharmacokinetic and pharmacodynamicinformation);- Marketing Department Support: Assessment of Monograph and promotional material’s review.Preparation of scientific manuals. Show less

Regulatory Affairs:- Submission of Marketing Authorization Applications by natinal and MRP/DCP procedures,- Submission of Type II variations (quality and safety) and Type I variations,- Submission Marketing Authorization Holder Renewal Applications,- Preparation of Standard Operation Procedures for Regulatory Affairs Department,- Marketing Department Support: Assessment of Monograph and promotional material. Help with launch of new products. Health professional information… Show more Regulatory Affairs:- Submission of Marketing Authorization Applications by natinal and MRP/DCP procedures,- Submission of Type II variations (quality and safety) and Type I variations,- Submission Marketing Authorization Holder Renewal Applications,- Preparation of Standard Operation Procedures for Regulatory Affairs Department,- Marketing Department Support: Assessment of Monograph and promotional material. Help with launch of new products. Health professional information and newsletter of company.- Submissions of Marketing Authorizations Applications outside Europe.Pharmacovigilance:- Preparation of Periodic Safety Update Report (PSUR's);- Preparation and submission of CIOMS;- Responsible for Pharmacovigilance line (scientific, safety and efficacy questions about medicines market by Tecnifar, S.A.);- Preparation of Standard Operation Procedures for Pharmacovigilance and PSMF;- Eudravigilance submissions and update of database;- Pharmacovigilance training of internal employee and force sale team.Scientific information and trainning:- Scientific training (pharmacological, pharmacokinetic and pharmacodinamic;information) about medicines marketed by Tecnifar, S.A.;- Launch of new products.Deputy and Technical Director Support. Show less

Regulatory Affairs activities and Technical director Support.