Eumedica Pharmaceuticals AG is an international Pharmaceutical company that maintains on the market essential medicines in specific and rare diseases.
We live and deliver every day our motto ”Ensuring Medical Care Continuity”.
Based in Basel, we are looking for talented and dynamic profiles to complete our teams and support our ambition to grow further.
In the scope of extension of our activities in our site in Basel, we are looking for motivated and experienced professionals.As a
Regulatory Affairs Associate (Pharma)
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 post-submission phases of selected products. Furthermore, you will maintain regulatory records and databases.
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
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
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: firstname.lastname@example.org
We are looking forward to meeting you very soon!
Eumedica Pharmaceuticals AG
Mr Holger Bornemann
Head Regulatory Affairs
Arnold Böcklin Str 1