pharmalex_job_career

We are growing, grow with us

Want to work in a dynamic company with daily new challenges and opportunities?  Then is PharmaLex your career opportunity.
 
PharmaLex is one of the leading service companies for the global pharmaceutical industry and specializes in all aspects of drugs and medical devices approval of the development to market and any action to product maintenance make it as effective as possible.
The success of our company grows with the excellent expertise and the high motivation of our employees.
If your profession is not only a job for you but also a mission, and if you enjoy working with people and in teams, then you are highly welcome to join us. 

To strengthen our successful team in Belgium, we are looking, as earliest as possible for a:

(Senior) Manager Regulatory Affairs

Your Job

  • Planning and implementation of approval procedures in the EU (MRP, DCP, CP and purely national procedures) as well as of life cycle management procedures (variations, renewals, MAH transfer etc.) worldwide
  • Offer expertise to the global PharmaLex team on national requirements for Belgium and for other Benelux states, including provision of national regulatory intelligence and review of national documents, labelling texts and artwork
  • Communication with the project team, with customers, local partners and authorities in an international context

We offer you

  • Diversified and challenging job opportunity
  • Cooperative and sharing atmosphere within a highly knowledgeable team
  • Flexible working hours, trust based leadership style
  • Continuous development opportunities

Your Profile

  • You have successfully completed a degree in pharmacy, medicine or other life sciences
  • You have at least 3 years of professional experience in EU Regulatory Affairs (new applications and variation management) with a focus on Belgium/ BeneLux and ideally
  • You have sound knowledge of current pharmaceutical and regulatory requirements (EU)
  • You have experience in labelling and artwork management for BeneLux, are able to work independently, you are multi-tasking capable, and enjoy consulting of customers
  • You are a team player, communicative, conscientious, accurate and responsible
  • Flexibility and willingness to travel
  • Confident MS Excel and Word knowledge as well as French or Dutch mother tongue and business fluent English skills complete your profile