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RA Professional (Benelux) - Belgium  

Phara_consulting (company)


Posted on : 16 November 2016

Project Description

We are a consultancy firm in EU regulatory affairs, located in Antwerp. We provide strategic and hands-on regulatory support in various therapeutic areas ranging from life-threatening diseases to OTC and borderline products. We are looking for a Regulatory Affairs Professional with 3-6 years of experience in Benelux regulatory affairs to join our team.  

Job Description:
Your main focus will be regulatory activities at Benelux level.  

Depending on your level of experience, you will, for our clients:  
  • Manage or support a product portfolio and interact with national competent authorities on regulatory submissions in Benelux countries. 
  • Support the European regulatory affairs groups with local regulatory intelligence information and contribute as appropriate to the regulatory strategies. 
  • Interact with colleagues from European headquarters at client companies with regard to the collection of information necessary for submissions and to address questions from competent authorities. 
  • Be responsible for, or assist with, the preparation, submission and follow-up of marketing authorization applications and variation files, in line with national Benelux regulatory requirements, scientific principles, and company policies and procedures. 
  • Assess material for publicity and information purposes and compliance of scientific/commercial events in the Benelux territories. 
  • Contribute to the maintenance of quality systems and SOP writing. 
  • Master in Pharmaceutical Sciences or equivalent with minimum 3 years of experience in Benelux regulatory affairs. 
  • Experience with review and approval of publicity and medical information is an asset. 
  • Proficient oral and written Dutch, French and English language skills; German is a plus. 
  • Ability to foster relationships with internal and external stakeholders (such as RA colleagues, medical affairs, commercial, market access, pharmacovigilance, and competent authorities). 
  • Diligent to work in compliance with regulatory legislation and Quality Assurance systems. 
  • Ability to adapt to different client company cultures and service minded attitude. 
  • Accurate, proactive, reliable, hands-on, and quality output driven. 
  • Maintain product portfolio overview, proven ability to meet deadlines and set priorities. 
  • Positive and pleasant personality with effective interpersonal skills. 
  • A competitive salary. 
  • Varied job in a young and dynamic environment. 
  • Continuous learning and exchange of expertise with seasoned regulatory affairs colleagues.