Ana Arede Email & Phone Number

Lisboa, Portugal

Alcabideche, Lisboa, Portugal

- Regulatory management of Marketing Authorization dossiers of Medicinal Products – national, european and third countries markets (e.g Saudi Arabia, EAU, Vietnam etc.);- Submission and follow-up of MA applications via national, MRP and DCP;- Coordination of regulatory activities with authorities, plant and partners;- Lifecycle management such as MA variations and renewals;- Analysis /revision of technical documents (e.g quality documents from plant); - eCTD and NeeS format compliance- Artworks revision

- Preparation, submission and follow-up of Marketing Authorization dossiers to the Regulatory Authority of Medicinal Products of Human Use (NP, MRP or DCP, Portugal as RMS or as CMS); - Preparation and submission of MA variations (by National Procedure, MRP or DCP);- Consolidation of quality module of MA dossier; - Elaboration of Patient Information Leaflets, Readability Tests Reports and Bridging Reports; - Update and maintenance of products’ portfolio/databases; - Technical translation of SPC, PIL and labeling and harmonization with current QRD template); - Pharmacovigilance activities (New MA registration, invalidations and updates in XEVMPD); - Batch releases.

Lisboa E Região, Portugal

Regulatory Affairs advice and support:- Preparation of applications for marketing authorisation dossiers submission (through National Procedure, MRP and DCP) in NeeS and e-CTD format;- Marketing authorisation activities such as line extensions applications, variations, renewals, marketing authorisation transfers; - Consolidation/updating of quality part of the MA dossier;- All activities related to the MA assessment phase for MA granting (e. g. follow-up and contact with the authorities, preparation and submission of letter of deficiencies’ responses, regulatory guidance);- Revision of packaging material, preparation, translation and revision of SPC, PIL and labelling according to QRD and applicable guidelines for regulatory compliance; - Prices and reimbursement requests submission; - Readability Tests and Bridging Reports preparation; - Pharmacovigilance activities (PSURs and Risk Management Plan preparation, literature search, XEVMPD);- Addendum to the Clinical Overview preparation Clinical and Nonclinical Overviews preparation; - Cosmetics and food supplements registration in the competent authority.