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 for you, your profession is not only a job but a mission too and you enjoy working with people, then you are welcomed to come and join us.
 
To strengthen our successful team, we are looking, as earliest as possible for a:

Manager Regulatory Affairs CMC

Your Job

  • Under general direction, preparation and project management for the CMC (m3 and 2.3 CTD modules)

We offer you

  • Diversified and challenging job
  • Open and collaborative organisational culture with emphasis on knowledge-sharing
  • Flexible working hours
  • Continuous development opportunities through knowledge and experience as well as training
  • Location: Madrid or Zaragoza

Your Profile

  • Successfully and completed degree in sciences (preferably pharmacy, chemistry or biology). A Master degree in Regulatory Affairs might be considered an advantag
  • At least 3-5 years of professional experience in Pharmaceutical_Quality with a focus on regulatory aspects of the pharmaceutical quality documentation
  • Technical/project management experience
  • Ability to manage several projects with limited guidance
  • Practical experience in regulatory submissions (MAA, CTA, CEP, Life Cycle Management processes etc.) and in Regulatory Compliance
  • Independence, flexibility and motivation
    Excellent communication skills, team spirit and social competence
  • Fluency in English, spoken and written (C1 Advanced)
  • Computer literacy and confidence with business applications