Deadline for applications:
Monday, 31 December, 2018
- Life cycle support for registered medicinal products (EU regulatory affairs).
- Creation, adaptation and verification of registration dossiers in e-CTD format (new products, product variations, 5-year renewals).
- Assist in the vigilance activities for medicinal products, medical devices and cosmetics in compliance with the current European and national (Benelux) legislation.
- Verification of medicinal product artwork and translations.
- Verification and scientific review of promotional materials for medicinal products.
- Keep up-to-date with current European and Belgian legislation for medicinal products, medical devices, nutrients, cosmetics...
- At least a Bachelor’s Degree in life sciences
- Candidates with proven experience in a comparable function or those who are familiar with the field's concepts, practices, and EU regulatory affairs procedures have an advantage.
- Outstanding interpersonal and communication (written and verbal) skills are required: the ideal candidate is trilingual (Dutch / French / English) CEFR level B1 or higher.
- Multitasker, able to cope with a broad range of projects, high stress levels and time pressure.
- Diplomatic and flexible personality, proactive, being able to function alone and in a team.
- Focused on detail and systematic in approach.
- Proficient with computer and standard software programs (Word, Outlook, Excel,…).
- Only candidates living in Belgium will be considered, candidates living in the area Antwerp – Brussels – Leuven have an advantage.
- An environment where autonomy and entrepreneurship are stimulated.
- The chance to participate in projects that influence the company strategy over the coming years
- International context.
- Salary dependent on relevant experience + extra-legal benefits.
- A full-time function is offered
- Applications + a detailed cv should be sent in Word format to hr [at] archemin.eu before the expiry date.
- All applicants will receive a reply.
- The procedure will involve one or more face-to-face interviews