Archemin

Advice & reporting for the chemical and pharmaceutical industries

Regulatory Affairs Manager

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