Dylan Dooley

Experience

• 

  Almotech

  Jun 2014 - Aug 2016

  Graphic Designer
• 

  South William Street Pharmacy

  May 2017 - Sept 2017

  Healthcare Assistant
• 

  Hickey's Pharmacy

  Jan 2018 - Apr 2018

  Healthcare Assistant

  Part-time 12 week experiential learning internship as part of RCSI's APPEL 12-week longitudinal community pharmacy placement.Roles and responsibilities:Processing of prescriptions under the supervision of a pharmacistGeneral OTC salesPatient consultationsStock management

• 

  Royal College of Surgeons in Ireland (RCSI)

  Jun 2018 - Sept 2018

  Mechanobiology Research Student

  Summer mechanobiology research position as part of the RCSI Research Summer School (RSS) and RCSI Tissue Engineering Research Group (TERG) under The Wellcome Trust Biomedical Vacation Scholarship. The Effect of Substrate Stiffness on Chondrocytes: A Model for Tidemark Reactivation in Osteoarthritis.Project Aims:>Fabrication of polyacrylamide (PA) hydrogels of varying stiffnesses (10, 100 & 300 kPa).>Morphological assessment of chondrocytes cultured on PA substrates.>Measurement of altered chondrocyte gene expression as a function of substrate stiffness. Show less

• 

  Health Products Regulatory Authority (HPRA)

  May 2019 - Dec 2019

  Scientific Affairs Intern

  Seven-month internship with the Scientific Affairs section of the Quality, Scientific Affairs and Communication department of the Health Products Regulatory Authority. Responsibilities included conducting classification reviews of medicinal products, medical devices and cosmetics in cooperation with the HPRA classification committee and the management of medicines shortages on the Irish market as part of the HPRA medicines shortages framework.

• 

  University College Dublin

  Jun 2020 - Aug 2020

  Research Assistant

  Eight week summer research project with UCD School of Medicine.Project: Development of a hydrogel system for sustained localised drug delivery in spinal cord injury.Skills and competencies:>Fabrication of hydrogels;>Tissue culture;>Microscopy;>Immunohistochemistry;>Scientific writing.

• 

  European Medicines Agency

  Oct 2020 - Jul 2021

  SME Office Trainee

  10-month traineeship with the SME Office of the EMA's Regulatory Science and Innovation Task Force (TRS).Roles and Responsibilities:• Horizon scanning technologies in SMEs and pipelines, focusing on priority areas, including advanced therapies, medtech, polymers, and biological proteins/peptides.• Analysing the sources of innovative medicines emerging from academia and SMEs in Europe.• Responding to regulatory assistance queries and participation in SME Office Briefing Meetings.• Provision of procedural support to SMEs in EMA procedures – e.g., orphan drug designation, scientific advice, marketing authorisation applications, etc. • Reviewing regulatory documentation and submissions, and handling of confidential and commercially sensitive data.• Participation in Innovation Task Force meetings.• Drafting of articles for internal and external publication. Show less

• 

  Health Products Regulatory Authority (HPRA)

  Nov 2022 - now

  Assessment of the pharmaceutical aspects of new applications for veterinary medicinal products and variations to existing authorisations for pharmaceutical products containing new chemical entities or established active ingredients.Responsibilities:• Conducting scientific evaluation of pharmaceutical data submitted in support of: - National applications for marketing authorisations, including Parallel Products - EU applications when the HPRA is acting as Reference Member State in a mutual recognition, decentralised or subsequent recognition procedure - Centralised applications to the EMA for marketing authorisations when the HPRA is acting as rapporteur, co-rapporteur or peer reviewer on behalf of the EMA - Centralised scientific advice applications where the HPRA is acting as coordinator on behalf of the EMA• Preparation of assessment reports on applications for and variations to marketing authorisation for veterinary medicinal products and submission of reports to other EU member states when the HPRA is acting as Reference Member State in a mutual recognition or decentralised procedure• Analysis in the context of public health, of risk-benefit profiles in respect of applications for marketing authorisations; making recommendations and preparation and presentation of reports to the Board, Advisory Committees and Sub-Committees or the Management Committee of the HPRA, and/or the CVMP or their representative working parties. Show less Scientific Officer in the Pharmaceutical Assessment section in the Veterinary Sciences department. Key responsibilities include: o Assisting in the evaluation of the pharmaceutical aspects of routine applications for renewal or variation of product marketing authorisations.o Assisting in the evaluation and finalisation of labelling, public assessment reports and in the related aspects of applications for marketing authorisations.o Assisting in the maintenance of the computer databases and information systems of the Health Products Regulatory Authority (HPRA) relating to veterinary medicinal products. Show less

  • Pharmaceutical Assessor

    Jun 2023 - now

  • Scientific Officer

    Nov 2022 - Jun 2023