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Regulatory Affairs Associate (Pharma)

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Eumedica is an independent pharmaceutical company specialized in the production and distribution of niche hospital products. We aim to ensure continuity of care for patients with serious, even rare diseases. Our portfolio is mainly focused in gastroenterology, anti-infectives and antipsychotics and products are registered in total in more than 30 countries worldwide. In the scope of extension of our activities in our site in Basel, we are looking for motivated and experienced professionals. 

Regulatory Affairs Associate (Pharma)

As a Regulatory Affairs Associate you will contribute to the filings of administrative, medical-scientific and technical changes, as well as renewals and new registrations to health authorities worldwide (EU/CH, Africa, MENA, SE-Asia). Under some guidance, you will support various regulatory activities throughout the application and postsubmission phases of selected products. Furthermore, you will maintain regulatory records and databases.

Key responsibilities 

  • Regulatory affairs artwork & labelling management
  • Prepare and update regulatory module 1 documentation for product transfer and variation applications
  • Liaise with internal & external regulatory affairs parties as well as other department to obtain the needed data for compilation of regulatory documents
  • Update product information & packaging components in compliance with regulatory guidelines
  • Assist in or prepare regulatory submission sequences
  • Assist in maintaining regulatory compliance of product registrations
  • Contribute to review and provision of regulatory advice for change controls
  • Maintain regulatory records and databases
  • Administrative tasks

Education/Experience 

  • Degree in Science (e.g. Pharmacy, Chemistry or Biology) or equal level achieved during years of working experience
  • Relevant experience in the pharmaceutical industry and regulatory affairs environment for minimum of two years
  • General working knowledge with EU regulations and regulatory guidelines for pharmaceutical products
  • First experience in updating product information and artwork management for EU & emerging markets is required
  • Familiarity with maintenance of regulatory databases & eCTD software • Fluent in English and good command of German or French 
  • Excellent knowledge of MS-Office applications

We offer 

  • A position in a successful, fast-growing company
  • A dynamic and ambitious environment with very diversified tasks
  • The opportunity to create and build-up new processes

Ready to take-up a new challenge? Then please send your complete application dossier in one pdf-file to: jobs@eumedica.ch. We are looking forward to meeting you very soon!

Adresse

Eumedica Pharmaceuticals AG
Mr Holger Bornemann
Head Regulatory Affairs
Arnold Böcklin Str 1
4051 Basel
061 205 3130

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