Regulatory Affairs Specialist (f/m) 100%
Zürich / Oerlikon, International/Corporate
Acino is a Swiss pharmaceutical company, leader in advanced drug delivery technologies. We have a clear focus on selected emerging markets in the Middle East, Africa, the CIS Region, and Latin America, and we operate in some of the most dynamic countries of the world. We value courage, commitment, trust, and empathy and provide an environment that supports initiative and effort. We are proud to be action-oriented and open-minded, with a strong focus on quality and product availability, even in remote and hard to reach areas of the world.
Your main responsibilities include:
- Support of regulatory managers in all administrative aspects
- Regular tracking and documenting of Product Information updates (EU & CH) in Health Authority portals according to Acino processes
- Organize the maintenance of printed packaging materials (EU & CH)
- Provide timely Regulatory Intelligence updates (EU&CH) to the RA team members
- Responsible for the RA contract database
- Uploading of documents and dossiers into Document Management System (Docubridge)
- Support of regulatory managers in terms of preparation of new marketing authorization applications and variations (e.g. preparation of Module 1, compilation of application forms)
- Uploading of dossiers via electronic portals (to Health Authorities)
- Overall responsibility for the electronic RA solutions (DMS, eSub tool, RIMS)
- Support the dispatch of dossiers to third party (customers, partners, distributors, etc.)
- Life science degree or equivalent
- Experience in a pharmaceutical industry especially in regulatory affairs with focus on eCTD & Product Information
- Excellent planning and organizational skills with capability to prioritize tasks and adhere to timelines
- Excellent computer skills – MS Office applications exp. Word and Excel, eCTD / Document Management Systems (experience with docuBridge is an advantage)
- Able to work in an international and interdisciplinary environment
- Team player with good communication skills
- Fluent in German & English (written and oral) is a must; any further languages are an advantage
- Target oriented, multi-tasking and able to work under pressure
This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you! Please send us your complete application to – preferably via e-mail into one PDF document – to Ms. Emmanuelle Leblanc.
We are looking forward to the opportunity to get to know you.
Only direct applications are considered.