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Junior Regulatory Affairs Scientist/Writer - Belgium  

Phara_consulting (company)


Posted on : 19 July 2017

Project Description

  • Our company is a consultancy firm in EU regulatory affairs,(5 min. walking distance from the central station).  
  • We provide strategic and hands-on regulatory support in various therapeutic areas ranging from life-threatening diseases to OTC and borderline products.
  •  By concentrating exclusively on regulatory affairs, we can offer in-depth knowledge, insight, skills, and experience. 
  •  We have a unique team of junior and senior consultants in place with a heart and talent for regulatory affairs. 
  • Our company  is looking for a Regulatory Affairs Scientist and/or Regulatory Affairs Scientific Writer to join our team.  

Job Description  
  • Supported by our team, you will support our clients in scientific aspects of regulatory affairs of medicinal products. This can include:   
  • A role as Scientific Writer of several parts (quality i.e. CMC information, non-clinical information, clinical information) of dossiers (such as clinical trial applications, scientific advice briefing books, orphan drug designations, pediatric investigation plans, MAAs/Variations) that will be submitted to the regulatory authorities. 
  • Contribution to defining a sound regulatory scientific strategy for development and life cycle management of medicinal products. 

  • Bachelor, Master or PhD in a scientific discipline relevant to the development and life cycle management of medicinal products e.g. pharmacy, biology, chemistry, biomedical sciences, bio-engineer. 
  • Scientific background and keen interest in scientific aspects of medicinal products. Scientific background in specialized areas of medicinal product development such as biologicals, infectious diseases, oncology, immunology or other is a plus. 
  • Exposure to or initial experience with regulatory affairs and elements of drug regulation is an asset. 
  • Excellent language skills in English, Dutch. French is a plus. 
  • Clear and effective written and oral communication skills. 
  • Very good writing skills in English and passionate about analyzing scientific information and presenting scientific data in an accurate and clear way. 
  • Capable to efficiently work with MS Word, Excel, Power Point. 
  • Proactive attitude and fast learner. 
  • Customer minded and quality output driven. 
  • A dynamic person and team player who can operate in a flexible working environment. 
  • Positive and pleasant personality with effective interpersonal skills. 
  • Ability to cope with changing priorities and multi-tasking. 

  • A competitive remuneration package. 
  • Varied job in a young and dynamic environment. 
  • Coaching by seasoned regulatory affairs colleagues, passionate by regulatory affairs. 
  • Opportunity for continuous learning and to follow external training courses