Telma Horta Antunes Email & Phone Number

Lisbon Metropolitan Area

- Create strategy for EU and non-EU submissions;- Perform audits of the dossiers;- Strong background and experience in all CTD Modules;- Preparation and consolidation of dossiers for MA applications (NP, DCP and MRP - EU and non-EU), post-approval/post-marketing lifecycle management;- Responsible for coaching and mentoring new and existing members and develop their knowledge and expertise in lifecycle management of medicinal and health products;- Ensure the maintenance of the main regulatory activities developed at international level.

Lisbon Metropolitan Area

- Submission and management of the MA applications, variations and renewals in international markets (EU and non-EU), including cosmetics and food supplements processes;- Preparation of Modules 1, 2 and 3, submission and follow up (deficiency letters response) in EU and outside EEA (Africa, MENA, GCC, MENA, Asia, New Zealand, LATAM);- Experience in MA applications under different types of procedures (NPs, MRPs, DCPs in the EEA) and legal basis (WEU, hybrid, generics);- Bibliographic research and update of clinical and non-clinical reports for EU submissions;- Regulatory compliance and consolidation in eCTD format of the medicinal products dossiers;- Preparation and revision of SmPC, PIL and Labelling; - Review and approval of artworks internationally marketed.

Lisbon Metropolitan Area

- Assist in compilation and submission of regulatory documents to the local authorities (Portugal and other countries: GCC, FWA, Nigeria, Mozambique, Cape Verde and Hong Kong);- Provide assistant in the update of clinical and non-clinical reports by performing bibliographic and medical research;- Reformatting CTD to eCTD of Module 3;- Preparation of the variation’s packages for the submission in Infarmed;- Update of PIFs for cosmetic products and labelling compliance;- Technical translation of scientific documentation related to medicinal products, cosmetics and food supplements;- Review and translation of product information and artworks.

Lisbon, Portugal

Lisbon, Portugal

- Preparation, handling, storage and dispensing of medicines;- Pharmaceutical advice and pharmacotherapeutic follow-up;- Control of the expiration dates and storage conditions of products;- Reception of orders from suppliers/wholesalers and controlling stocks.

Master In Pharmaceutical And Parapharmaceutical Industry

- Scientific Area: Pharmacovigilance, Medical Affairs, Clinical Trials, GCP and Scientific Documentation; - Pharmaceutical Marketing.

Integrated Master'S Degree, Pharmaceutical Sciences

Pharmacy Intern - Curricular Internship January 2014 - May 2014 | Farmácia São José (Coimbra) - Elaboration of the Quality Management.