Regulatory Affairs Specialist - Lucerne
- Company
- CK Clinical
- Location
- Lucerne
- Salary
- 51.00 - 63.00 CHF per hour
- Posted
- 22 Feb 2021
- Closes
- 24 Mar 2021
- Ref
- 49949
- Contact
- Jocelyn Blackham
- Discipline
- Medical Affairs
- Hours
- Full Time
- Contract Type
- Contract
- Experience Level
- Experienced (non-manager)
Jocelyn Blackham is recruiting for a Regulatory Affairs Specialist to join a leading biopharmaceutical company at their site based in Lucerne on a contract basis for 10 months.
The main purpose of the Regulatory Affairs Specialist will be to provide regulatory administrative support and coordination for the department with maintenance of tracking systems and databases, minor translations, preparing submissions, renewals, PSURs, local files, minor translations and artwork management.
Further responsibilities will include:
Please could you send any correspondence in English. Please quote reference QLS in all correspondence.
The main purpose of the Regulatory Affairs Specialist will be to provide regulatory administrative support and coordination for the department with maintenance of tracking systems and databases, minor translations, preparing submissions, renewals, PSURs, local files, minor translations and artwork management.
Further responsibilities will include:
- Coordination and submission of variations and renewals
- Updating product Information, Marketing Authorisation transfer and other product Life cycle management related activities
- Data input in Databases
- Document Management Systems
- Previous experience within a related fiend
- Relevant scientific qualifications
- Experience with MS Office Products (Excel, Word), Databases, Document Management Systems
- Previous experience with Swissmedic
- Fluent German + English. Other languages including Italian and French are highly desired.
Please could you send any correspondence in English. Please quote reference QLS in all correspondence.