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Manager Regulatory Affairs (m/f) - Spain  

Company managed [?] Still accepting applications
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Posted on : 06 April 2017

Project Description

Be a part of our growing company!
  • Are you eager to work in a dynamic company where new challenges and opportunities are part of your every day life? 
  • Then make our company  your career choice! 
  • Our company  is the leading service provider for the worldwide pharmaceutical industry in regulatory affairs, pharmacovigilance and development consulting.
  •  We are specialized in effectively designing all aspects of drug and medicinal product registrations – ranging from early development and market entry to product maintenance activities. 
  • The success of our company resides in the expert knowledge and high motivation of our employees.
  • We are looking for motivated, committed candidates who will enjoy working independently within our successful team in a challenging environment.
  •  So, if your career is much more than just a job for you but rather your passion, then come and join our successful team. 

Your Tasks
  • Compile and check pharmaceutical quality documentation (Module 3, QOS, IMPD, ASMF etc.) for national and international markets
  • Prepare Gap Analyses of pharmaceutical quality dossiers in the context of marketing authorization projects, Due Diligence
  • Set up responses to deficiency letters from authorities
  • Supervise development projects and marketing authorization procedures with regard to the pharmaceutical quality documentation
  • Compile and review Product Quality Reviews (PQRs)
  • Coordinate and perform CEP procedures
  • Coordinate and perform Life Cycle Management processes with regard to the pharmaceutical quality documentation (change control procedures, prepare and submit variations, site transfers etc. with regard to strategy and content)

Your Profile
  • Degree in natural sciences (preferably pharmacy, chemistry or biology)
  • Fluency in English, spoken and written
  • Independence, flexibility and motivation
  • Excellent communication skills, team spirit and social competence
  • Highly service orientated
  • Computer literacy and confidence with business applications

Good to have
  • Experience in Pharmaceutical Quality with a focus on regulatory aspects of the pharmaceutical quality documentation
  • Practical experience in regulatory submissions (MAA, CTA, CEP, Life Cycle Management processes etc.) and in Regulatory Compliance

We offer you
Exciting and varied challenges in a friendly, team, contact and interaction with nearly all branches of the company, as well as many opportunities for personal development and job training