Johnson & Johnson
NL - Regulatory Affairs Consultant - Dossier Development and Operations Technical Integrator
Johnson & Johnson is currently recruiting a RA Consultant - Dossier Development and Operations Technical Integrator for our Janssen Vaccines & Prevention site in Leiden.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science, bringing innovative ideas, products and services to advance the health and well-being of people.
As a RA Consultant - Dossier Development and Operations Technical Integrator you are responsible for writing Modules 2.3 and 3 of Vaccines IND/IMPD, MAA/BLA dossiers.
- Ensures compliance with regulatory agency regulations and interpretations.
- Prepares responses to regulatory agencies' questions and other correspondence.
- Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
- Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
- Provides solutions to a variety of problems of moderate scope and complexity.
- Organizes and maintains reporting schedules for new drug application and investigational new drug applications.
- 3-5 years experience in writing these dossiers and in Module 2.3 and Module 3 Dossier Development.
- Good communicating skills (written and verbal).
- Able to work in CMC (Chemistry, Manufacturing and Controls) Teams.
- Great attention for detail.
- Hands on experience in documentum based systems.
- Degree in pharmaceutical sciences, biochemistry, biology, biomedical science or chemistry.
- Flexible working hours.
- Currently you will work remotely because of COVID-19.
- This is a contracting position, with the possibility of an extension after the end date. You wil receive a contract via our partner Yacht. Yacht can offer you a payroll contract for the duration of the assignment at J&J or a freelance (ZZP'er) contract.