Description / Requirements
Our client is an innovative Greek pharmaceutical company that wishes to employ 2 Regulatory Affairs professionals at the level of Senior Officer and Officer respectively.
- Coordinates and participates in preparation of different types of regulatory submissions (e.g. dossier, variations, and scientific advice submissions) to competent authorities worldwide for approved and developmental products.
- Contributes to and implement, execute the filing plan for relevant countries.
- Preparation of registration files (Centralized, Decentralized, Mutual and National procedures)
- Communication with public authorities regarding new registrations, variations and renewals as well as monitoring of labeling and packaging issues, ensuring adherence to legal requirements.
- Conducts proper assessments in order to anticipate questions and critical issues.
- Reviews and updates CMC (chemical-manufacturing control) data.
- Monitors and evaluates the impact of the local legislation changes of each country on business activities and guarantees organization readiness to address them proactively and aligns local regulatory affairs goals to strategic functional objectives.
- Prepares and ensures regulatory submissions are made on time and meet company’s corporate and local regulatory requirements.