Chefe de site, garantia de qualidade

Team and projects management. Regulatory affairs consultant and Experienced project manager on the following areas:- Human Medicinal products: MA Applications under different types of procedures (NPs, MRPs, DCPs in the EEA as well as Medicinal products registration in 3rd countries, e.g. outside the EEA) and legal basis, Variations and Renewals under the different types of procedures (NPs, MRPs, DCPs) in the different possible formats (CTD, NeeS, e-CTD, etc); Preparation, translation and revision of texts for SPC, PIL and Labelling; Importation and Exportation licences application. Training: Internal department collaborators training and University internships supervisor. External eCTD training. 

Team management; Active pharmaceutical ingredient (API) manager; responsible for EU-GMP audits compliance, new API’s qualification and post-MA variations management. Quality expert reports. IMPD constitution. Regulatory advice. Constitution, submission and management of new EU Marketing authorizations (MA) by National (EU and non-EU countries), Decentralised and Mutual Recognition procedures (CTD and eCTD format). Marketing authorisation maintenance activities: variations and renewals via National (EU), Mutual Recognition and Decentralised procedures.
Post Marketing management including preparation, review, submission and monitoring of all types or variations (Type I and Type II).
Management of licensees, business partners, clients and Competent Authorities relationships

Quality expert reports. IMPD constitution. Regulatory support. Constitution, submission and management of new EU Marketing authorizations (MA) by National (EU and non-EU countries), Decentralised and Mutual Recognition procedures (CTD and eCTD format). Marketing authorisation maintenance activities: variations and renewals via National (EU), Mutual Recognition and Decentralised procedures. Post Marketing management including preparation, review, submission and monitoring of all types or variations (Type I and Type II).

Analytical methodology development.
Validation of analytical methodology for drug substances and drug products.
Analytical pharmaceutical development of generics drug products.
Constitution of regulatory documentation for the drug product MA submission.
Good Manufacturing Practice and Validation.
Drug analysis and Quality Control.

Methodologies experience: Current laboratory technics, HPLC, GC/MS, GC/FID, GC/olfactory, Flash Chromatography