We are growing, grow with us!
Want to work in a dynamic company with daily new challenges and opportunities?  Then PharmaLex is 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 also a vocation and you enjoy working with people and in teams as part of a global organization, then you are very welcome to join us.
To strengthen our successful team, we are looking as of now (independent of location in Germany) for a:

Specialist Regulatory Affairs (f/m/d)

Your Job

  • Support preparation of applications and handling of marketing authorizations in the DACH region (especially Germany, Austria, preferably also Switzerland)
  • Gain and adapt knowledge in handling of local requirements and national specifics in Germany, Austria and preferably Switzerland for regulatory submission activities incl. e.g. handling of national portals
  • Revision and adaptation of labeling documents including tracking of updates and their implementation
  • Support planning and implementation of approval procedures in the EU (MRP, DCP, CP and purely national procedures), as needed, as well as of lifecycle management procedures (e.g. variations, renewals, MAH transfer)
  • Communication and interaction within the project team, with customers, local partners and authorities in a regional and/or an international context
  • Revision of approval documents including tracking of updates and respective handling and updating of databases and document management systems

Your Profile

  • You have successfully completed preferably a degree in pharmacy, medicine or other life sciences or a bachelor’s degree in science
  • First experience in handling of marketing authorizations and their lifecycle management with a focus on the DACH Region and other EU countries would be an asset
  • You are a team player, communicative, conscientious, accurate and responsible
  • You are highly organized and have a focused working approach in order to deliver strong results under tight time frames
  • Confident with MS Excel and MS Word as well as databases and document management system
  • You speak fluent business German or German is your mother tongue, English language skills should be at least grade B2

We offer you

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

If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.

Your contact person:
Lena Schlager

Agencies only by prior agreement for the specific job opportunity.