Assistant Regulatory Affairs (f/m) 100%
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.
We are currently seeking an Assistant Regulatory Affairs in our Headquarter based in Zürich / Oerlikon
Your main responsibilities include:
- Support of regulatory managers in all administrative aspects
- Regulatory tracking of MoH portals for SmPC updates (EU & CH); document SmPC updates acc. to Acino processes
- Organization of all country specific certificates including translation and legalization (CPPs, CoAs, MLs, GMPs etc.)
- Preparation of country specific correspondence
- Organization of registration samples
- 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 to Health Authorities via electronic portals
- Creation and maintenance of internal project and milestone plans
Ideal personal profile:
- High school, PTA, CTA, MTA or similar education
- Experience in the pharmaceutical industry especially in regulatory affairs area
- Excellent planning and organizational skills
- Good computer skills – MS Office applications exp. Word and Excel, eCTD / Document Management Systems
- Able to work in an international and interdisciplinary environment
- Team player and good communication skills
- Fluent in German and English (written and oral) any further languages is of advantage
- Target oriented personality and able to work under pressure and on multiple tasks simultaneously
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. Sandra Gamboni. Sandra Gamboni / HR Site Head / email@example.com
We are looking forward to the opportunity to get to know you.
Only direct applications are considered.
If you are interested in working for a company that offers such challenging opportunities, we invite you to send your application along with all pertinent documents – preferably via e-mail in one PDF document – to Mrs. S. Gamboni, Human Resource Management.
Sandra Gamboni, Manager HR
Phone +41 44 555 22 00
We are looking forward to meeting you in person. Only direct applications are considered.Job list