Daniela Miranda

Regulatory Affairs Specialist, EMEA RMC Data Manager

Lisbon Metropolitan Area

About

As Regulatory Affairs Officer I developed projects in companies like Mylan, Pierre Fabre Medicament, Generis, Teva Pharma and Aurovitas Unipessoal.

Experience

  • Regulatory Affairs Specialist, EMEA Regulatory Management Center at Johnson & Johnson Innovative Medicine
    Apr 2019 - Present · 7 yrs 4 mos

  • Regulatory Affairs Consultant at Janssen Pharmaceutical Companies of Johnson & Johnson at ALTEN Portugal
    Oct 2018 - Mar 2019 · 6 mos

  • Regulatory Affairs and Pharmacovigilance Officer at Bluescience, Lda
    Sep 2016 - Sep 2018 · 2 yrs 1 mo

    Regulatory Affairs and Pharmacovigilance Officer at Bluescience - Preparation and submission of MAAs, preparation and maintenance of CTD dossiers; - Preparation and submission of variations and MA transfers; - Development and Management of regulatory files and databases; - Scientific translations to Portuguese and English and revision of PI and promotional materials; - Direct interaction with INFARMED; - Artworks management; - Pharmacovigilance of medicinal products (about 100 active substances):Literature Search (Bibliovigilance and PubMed); Signal detection and reporting of individual ADR's; MLM reports search.

  • Regulatory Affairs Officer Consultant at Mylan Portugal
    Aug 2018 - Aug 2018 · 1 mo

    Regulatory Affairs Officer Consultant at Mylan - Compliance

  • Regulatory Affairs Officer Consultant at Pierre Fabre Group
    Jun 2018 - Aug 2018 · 3 mos

    Regulatory Affairs and Intelligence Consultant at Pierre Fabre Medicament on behalf of Bluescience, Lda - Regulatory Affairs (Manage the life-cycle maintenance activities, Artwork management); - Regulatory Intelligence;