Beschreibung
Contract Regulatory Labelling Manager - Hannover - 12m - €70/hrOptimus Life Sciences are working with a global pharmaceutical client to find a contract regulatory labelling manager on a freelance basis. The contract will last an initial 12 months; this has the potential to get extended.
The role will be based full-time on site, but does not require any specific language skills other than English. The client is in need of departmental support within the global labelling department and the manager would like to run interviews, and decide on an applicant, before the end of August.
To apply for the job, or to find out more details, please send a CV over to Robert Marrett () to organise a more detailed call.
Tasks
- In charge with writing and updating the 'Patient Information Leaflet' text for authorised products.
- Offer regulatory guidelines for the preparation of SPCs for new products.
- Liaise with relevant project teams regarding the preparation, revision, review and issue of CCDs.
- Schedule and arrange PIL user testing projects with contract organisations Maintain CCDs in the Regulatory Affairs document management system.
- Monitor compliance of SPCs with CCDs across the associated companies.
- In charge of writing Clinical Expert reports.
- In charge of oversight of labelling for assigned products and sometimes new applications.
- All work must me in compliance with the CCDS and Labelling Change Control.
- Ensure deviations from the CCDS are documented and reported to the WLC committee.
- In charge of collecting regulatory data and collate to IDSCs in order for them to be included in GPSURs.
Requirements
- BSc in a Life Sciences discipline. MSc or PhD owners will have an advantage.
- Sound knowledge of International Regulatory Guidelines and relevant legislation.
- Minimum 3 years' technical regulatory experience.
- Minimum 5 years' management experience.