Deadline for applications:
Monday, 30 April, 2018
Job description:
Coordinate the activities of the team that is in charge of
- Life cycle management for registered medicinal products.
- Creation, adaptation and verification of registration dossiers in e-CTD format (new products, product variations, 5 year renewals).
- Verification medicinal product artwork and translations.
- Verification, scientific review and validation of promotional materials for medicinal products.
Collaborate closely with the business unit Market Access.
Remain up-to-date with current European legislation for medicinal products, medical devices, nutrients, cosmetics...
Profile:
- At least a Master’s Degree in life sciences.
- At least 5 years’ experience in a comparable function and being familiar with the field's concepts, practices, and EU regulatory affairs procedures.
- 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.
- Talent for the development of strategies; a wide degree of creativity and latitude is expected.
- Diplomatic and flexible personality, proactive, a genuine team player with proven people management skills. A good balance between hard and soft skills.
- Proven ability to plan, organize, monitor and control project processes.
- 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.
We offer:
- An environment where autonomy and entrepreneurship are stimulated.
- The chance to participate in projects that shape the company strategy over the coming years
- International context.
- Salary dependent on relevant experience + extra-legal benefits.
- A full-time function is offered.
Procedure:
- 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