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:

Specialist Regulatory Affairs Operations

Your Job

  • Prepare and contribute to the preparation/compilation/publishing of regulatory dossiers documentation for medicinal and/or biotech products
  • European dossier submissions in eCTD format (CP, MRP/DCP, renewals)
  • PSUR/PSUSA submission
  • Parallel import activities and packaging and labelling activities
  • Ensure compliance with the quality procedures
 

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

  • Degree in natural sciences (preferably pharmacy, chemistry, biology)  or documentation sciences.
  • Professional experience, familiar with European regulatory requirements for medicinal products is a plus
  • Distinctly strong service orientation
  • Fluency in English, spoken and written (C1 Advanced, might be considered an advantage)
  • Independent approach to work, flexibility and dedication
  • Strong communication skills, social competency, integration capacity
  • Strong sense of responsibility, organizational skills and intrinsic motivation