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Regulatory Affairs Associate (80/100%) Hoegaarden Belgium,  

Kasa Consultant (company)


Posted on : 10 November 2016

Project Description

tasks:
  • overall coordination and preparation of regulatory submissions and strategies 
  • manage the Clinical Trial submissions to competent authorities (ca) and ethic committees (ec) in belgium, the netherlands and france. negotiate and communicate effectively with ca and ec to obtain timely approvals 
  • develop and maintain regulatory knowledge of european regulations 
  • manage transposition of international standards into company related requirements 
  • provide advise and guidance to staff in order to keep them informed of the regulatory approval process and status. 
  • trigger and collect the necessary document inflow in order to obtain timely regulatory approvals 
  • defend company business interest in international standardization groups 
  • implement qc and qa systems

profile:
  • minimum 2 year of experience in a similar function in a CRO and/or in the Pharmaceutical sector 
  • excellent in social and interpersonal contacts 
  • able to handle multiple tasks to meet deadlines 
  • motivating people (Coaching, counseling, mentoring) 
  • customer-oriented, enthousiastic, dynamic 
  • excellent in dutch, French and English (oral as well as written) 
  • experience in Microsoft Office

Education, knowledge and experience
  • MSc Pharmacy, (para) Medical Sciences, or equivalent by experience
  • minimum 2 years of experience in a similar function  (preferably in a sme)

our offer
we offer you a challenging job with an interesting salary and extralegal benefits within a  pleasant work atmosphere and on a location without traffic jams. possibility of development of your personal skills via courses. 

Locations

Hoegaarden, Flemish Brabant, Belgium

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