Regulatory Affairs Project-Manager (m/f/d)

to expand our admissions department.

Your tasks

  • Independent preparation of approval-relevant documents in the field of pharmaceutical quality (Module 3)
  • Representation of AMW in customer discussions from the perspective of the regulatory affairs department, taking into account the aspects of development and quality control
  • Direct product responsibility and familiarization with the development backgrounds/quality optimization of the products
  • Independent summary of existing data from different departments into approval-relevant reports or eCTD dossier sections
  • Coordination of the approval-relevant communication with the customers and the specialist departments with partially independent creation of necessary documents
  • Project management of local approval processes

Your profile

  • University degree in
    • Medicine, pharmacy, approbation as a pharmacist or
  • PhD Preferred
  • Very good knowledge of the requirements of EU Module 3
  • Preferably knowledge of local quality requirements in LATAM, MENA, CIS countries
  • Sovereign way of working and joy to research and summarize the information independently
  • Experience in managing pharmaceutical/biotechnological projects
  • A high degree of communication skills, decision-making skills and the ability to work in a team
  • Interest in independent action
  • Very good knowledge of spoken and written English (C1-2 desirable)

Your perspectives

  • A challenging task in a fast-growing, international pharmaceutical company
  • A friendly and cooperative working atmosphere in the team
  • Be part of a highly competent and motivated team
  • Flat hierarchies and short decision-making paths
  • Numerous benefits such as flexible working hours, support with company pension schemes, job bike, free lunch and fresh fruit, as well as individual training opportunities

Have we aroused your interest?

Then send your application documents by e-mail to

We look forward to receiving your application!

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