Paula Vaccarello

-Guided and assessed regulatory and CMC development for a small molecule -Briefing books for Scientific Advice in the EU for 2 small molecules -Authoring ODD section for a gene therapy -Project coordination

-Guidance and assessment of regulatory, CMC and clinical development of 3 gene therapies and 3 small molecules -Authoring of IB, IMPD and IND sections for 3 FIH trials (gene therapy, cell therapy, mAb) -Preparation of CMC dossiers for global registrations and CMC lifecycle activities for 3 mRNA vaccines -Briefing books for 5 scientific advice procedures (3 gene therapies & 2 small molecules) -Support in ODD, PIPs and GMO applications for 8 products -Coordination of 4 projects

Consultant for pharma/biotech companies. -Scientific Advice in the EU for 2 ATMPs and 2 vaccines -IMPD and MAA/BLA lifecycle activities for 3 cell/gene therapies and an mRNA vaccine -Pediatric development of 2 ATMPs in the EU -Submission readiness for clinical trial and GMO applications for 5 gene therapies -Global clinical strategy for 3 ATMPS, a biologic and a combination product -Regulatory intelligence and policy analyses

Topic: Role of miR-21 in pulmonary fibrosis. Areas: molecular & cell biology, microRNAs, bioinformatics, lung disease. -Design, planning, documenting and conduction a research project -Participation in national conferences and scientific retreats with oral and poster presentations -Writing of SOPs and training of equipment users -Teaching in theoretical and practical courses

Conducting experiments in molecular biology.

Staff reinforcement during high season or employees holidays. -Sales -Management of social media

English-Spanish translator at 6 international music events. -Enabled communication between local and international crews. -Organized meetings, transportation and accomodation.

Design and conduction of a research project in organic chemistry.