We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.


Regulatory Affairs Senior Specialist

Your Job

  • Support with preparation of documents within the framework of regulatory affairs projects European  (CP, MRP, DCP, renewals, variations, and  country-specific procedures) and non-European in agreement with projects leads
  • Support with project work (e.g. compilation,  preparation and reviewing of documents) after adequate instruction
  • Support with preparation and handling of internal and external correspondence
  • Technical organization of training sessions, meetings, client visits etc. (e.g. room booking, setup and operation of presentation equipment)
Assist in optimizing and monitoring internal departmental organization:
  • Maintain internal departmental templates
  • Assist the project manager in project planning and organization.
  • Assist the heads of regulatory department and regulatory affairs teams

Your Profile

  • Basic experience of area of activity or similar field; ability to acquire knowledge "on-the-job"
  • Ability to work according to project plan and escalate potential issues according to agreed communication plan
  • Structured way of working; limited latitude within established set of procedures, may determine priorities with general supervision
  • Resolves routine (and some non-routine) problems in a thorough and timely manner. Attention to detail, High service orientation
  • Ability to prioritize and manage own time and tasks
  • Good communication skills (written and verbally); capability to point out issues and provide potential options for solution in the area of expertise. Confident appearance.
  • English language fluency

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.

Agencies only by prior agreement for the specific job opportunity.