Job Description
Key Responsibilities:
- Leading regulatory team of 2 Regulatory Associates
- Management of registration procedures to obtain registrations for generic medicines in line with local legislation
- Maintenance of existing registrations (variations, renewals), maintenance of regulatory data-bases
- Translations of SPCs, leaflets and labelling from English to Spanish and vice versa
- Reviewing approved product information in post-registration/production phase
- Planning coordinating and supervising all activities needed for obtaining marketing authorizations
- Communication with local authorities
- Monitoring of local pharmaceutical legislation and monitoring the practice and trends of the Spanish medicine agency
- Working closely with Regulatory affairs, Pharmacovigilance and QA headquarters and reporting to them
- Planning coordinating and supervising all activities needed for obtaining...