Regulatory Affairs Technician
hace 2 semanas
**Overall responsibilities**
To provide regulatory advice and support to the organization on the content of existing marketing authorizations and for products in development phase. Support pharmacovigilance department on safety relevant matters in line with national requirements
**Main Accountabilities**
- Obtain marketing authorizations for new pharmaceutical products:
- Maintain marketing authorisations as required
- Liaise with European Regulatory Affairs and Corporate groups on regulatory matters
- Liaise with national regulatory authorities as required
- Comply with the Company’s policies and procedures to assure consistency of the current local prescribing information with the CCDS in order to:
- Ensure alignment within the organization
- Meet the expectations of regulatory agencies
- Implement approved label through defined artwork process
- Main responsibility for arrangement of national Scientific Advice with national Competent Authorities
- Maintain awareness of current and new legislation/guidance and ensure that work is in compliance with the statutory requirements.
- Write and update local procedures in compliance with the local regulation and internal policies and procedures, if applicable
- Review of promotional and non-promotional materials in accordance with legislation, local procedures and codes of practice
- Experience with preparation of NeeS y eCTD dossiers.
- Bachelor of Health Sciences. Additional postgraduate training in the pharmaceutical industry or / and Regulatory Affairs is a plus.
- Minimum of 2 years’ previous experience working in a regulatory environment
- Experience in Drug Promotion regulations (legislation, self-regulatory codes...)
- Good knowledge of the European and national pharmaceutical legislation
- Good communication skills, both verbal and written
- The ability to thrive in a changing environment and to re-prioritize workload to meet business needs
- Good project management skills is essential
- Capacity for teamwork
- Flexibility to collaborate and support to other departments
- Very good English language skills
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