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 providers for the global pharmaceutical industry. We offer end-to-end regulated services and specialize in all aspects of approval and maintenance of medicinal products and medical devices. We support pharma companies throughout the entire product lifecycle, ensuring initial submissions and approvals as well as keeping compliance with pharmaceutical regulations worldwide.
Our services extend way beyond market approval, providing high level strategic consultancy as well as hands-on work to extend product registrations into new markets across all regions of the world.

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 for a:

(Senior) Manager Regulatory Affairs (DACH) (f/m/d)

Your Job

  • Planning and implementation of approval procedures in the EU (MRP, DCP, CP and purely national procedures) and in emerging markets as well as of lifecycle management procedures (e.g. variations, renewals, MAH transfer) worldwide
  • Preparation of applications and handling of marketing authorizations in the DACH region (Germany, Austria, Switzerland) including handling of local requirements
  • Communication and interaction within the project team, with customers, local partners and authorities in an international context
  • Revision of approval documents and text management (labeling management) including tracking of updates and implementation

We offer you

  • Diverse and challenging job
  • Open and appreciative corporate culture
  • Flexible working hours based on trust
  • Possibility to work part-time 
  • Possibility to work from home 
  • Continuous development opportunities through knowledge and experience as well as training

Your Profile

  • You speak fluent German (native speaker or grade C1-C2)
  • You have successfully completed a degree in pharmacy, medicine or other life sciences
  • You have at least 3 years of professional experience in marketing authorizations with a focus on the EU and in particular the DACH region (Germany, Austria, Switzerland). Experience in applications and handling of non-EU marketing authorization procedures is highly advantageous
  • You also bring experience in launch management (DE), labeling management and handling of clinical trial applications (CTA).
  • You have sound knowledge of current pharmaceutical and regulatory requirements (EU) and of local requirements in Germany, preferably also for Switzerland
  • You have experience in project management, you are multi-tasking capable, enjoy liaising with customers and have an affinity for databases and project management software
  • You are a team player, communicative, conscientious, accurate and responsible 
  • Flexible and willing to travel
  • Confident with MS Excel and MS Word
  • Fluent business English skills completes your profile