Regulatory Affairs Coordinator needed for a world-renowned pharmaceutical company. I am looking for a professional who supports the CSS Regulatory Affairs, Global Strategic Implementation Department in the execution of regulatory activities.
- Technical Dossier analysis of feedback provided to Notified Bodies and Questions received from Notified Bodies.
- Assists and supports the team members in the execution of regulatory strategies impacting all CSS for MDR Implementation and Execution,
- Gathers and assembles data necessary for the development of the regulatory aspects of project plans including tracking, planning, and communication,
- Assists in the execution of regulatory strategies for non-EU countries, including coordinating and tracking document requests,
- Creates and approves ECO’s pertaining to the Coordinator’s projects and duties (including but not limited to SOPs, EU labelling approval),
- Responsible for administrative tasks to support the CSS MDR activities including preparation of meetings and general administrative activities,
- Responsible for compiling reports, presentations and creating flowcharts,
- Researches, collects, cross-check data from different sources, and responds to requests from internal colleagues,
- Responsible for communicating business related issues or opportunities to next management level,
- For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable,
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures,
- Performs other duties assigned as needed.
- A university, bachelor’s degree or equivalent,
- 0-2 years of work experience, preferably but not limited to regulatory affairs (Technical File/Design Dossier/Technical Dossier preparations or submissions)
- Good command of database and spreadsheet software,
- Excellent written and verbal communication skills in English,
- Creative and advanced computer skills: Excel (mandatory), Power Point, One Note, Microsoft Teams
START DATE ASAP HOURS 40 hours a week (Flexibility to work remote)
DURATION 12 months with a high chance of extension LOCATION Remote / Diegem, Belgium
If you are interested in the above description, apply with your CV
PS: Did you also know that we offer an attractive referral scheme?
For more information, please contact Oliver Holding Fay on +31 (0)20 20 44 502 or firstname.lastname@example.org