Regulatory Affairs Coordinator 100% (Temporary)
Zurich / 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.
This is a temporary position is for one year.
Your main responsibilities include:
- Support of Regulatory Managers and Specialists in all administrative and operational tasks (incl. filing of documents to competent authorities, support in maintenance and keeping updated electronic databases)
- Maintenance of the CH&EU product information (SmPC, PIL, labelling) folder
- Uploading of documents (approved SmPCs & PILs and any other relevant document) to Health Authorities portals (CH&EU)
- Active communication with stakeholders for text updates for CH&EU following originator
- Creation and maintenance of printed packaging material for EU
- Manage general document translations
- Germany: BfArM/PEI: publication of manufacturers in AMIS/PharmNet.Bund
- Uploading of documents and dossiers into Document Management System (Docubridge)
- Maintenance of Symfact database
- Renewals in CH (as backup)
- Organization of all country specific documents including translation and legalization (CPPs, CoAs, MLs, GMPs, Price Certificates, Letter of Authorizations, etc.) (as backup)
- Maintenance and Updating of Artwork (all packaging materials) for CH (as backup)
- High school, PTA, CTA, MTA or similar education
- Experience in pharmaceutical industry especially within regulatory affairs and ideally with some exposure to labelling.
- Excellent planning and organizational skills
- Excellent computer skills – MS Office applications ( Word and Excel), eCTD / Document Management Systems
- Able to work in an international and interdisciplinary environment
- Team player with excellent communication skills
- Timely and effective collaboration with internal and external stakeholders
- Fluent in German and English (written and oral). Any further language is of advantage
- Target oriented personality and able to work under pressure managing multiple tasks simultaneously
- Excellent editing and proofreading skills with attention to detail.
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!
Isabela Gaspar Figueiredo
We are looking forward to the opportunity to get to know you.
Only direct applications are considered.
Apply & Further Information
To apply we invite you to send your application along with all pertinent documents – preferably via e-mail in one PDF document – to our HR team through the email listed below. The team is also happy to respond to any questions about the role or Acino, that you might have.
We are looking forward to hearing from you. Only direct applications are considered.Job list