Do you see yourself being part of multinational pharmaceutical company where you can use your experience in Regulatory area?
Do you have experience with OTC, MD or cosmetics?
Great opportunity is here!
Regulatory Affairs Manager:
- submission of labelling, quality changes (CCDS according to SOP)
- applications for new marketing authorization, translations of product information
- monitoring of the submission status with the authorities
- ensuring productlabeling is in-line with CZ and SK requirements (OTC, cosmetics, MD))
- submission of needed documents to health authorities (also being its contact person)
- updating of internal and external databases and document management systems (like BRAIN, Synaps, local compendia, etc.)
- colaborating with other region (SK) with development and marketing process by providing regulatory advice to internal partners
- liaison with authorities, global RA and local Medical Department
- ensuring compliance with all relevant global and local codes of practice