Supporting the RA-FDF Team and contributing in the regulatory activities in order to achieve the objectives of the department which are: obtaining global approval for CENTRIENT products, including the lifecycle management of the registration dossiers according to business planning.
Key Individual Accountabilities
- Collection of information and preparation of dossiers and variation packages as and when required
- Compilation and update of the product dossiers in portfolio for global and for customers registrations (Both NP and LCM) under guidance from Portfolio Lead and RA managers
- Support in activities related to pharmacovigilance
- Support in evaluation of CMC data required to support dossiers and variation packages
- Assist in the coordination of responses to questions raised by regulatory authorities during regulatory procedures
- Creation and updating of product information texts
- Keeping updated knowledge of relevant new/draft legislation/regulation/guidance in the global RA environment
- Cross functional alignment internally and externally in relation to regulatory updates, variations packages, and regulatory procedures
- Contribute to write and review SOP's related to department
- Report all regulatory data related to activities to ensure RA workplan and MA databases are up to date
- Support in MDS compliance and creation
- Escalating to senior RA staff in case of complex regulatory issues or risks including implications
Key Shared Accountabilities
- Ensure support to RA-FDF team and other disciplines within FDF and Centrient in order to meet objectives
- Execute on performance management and act accordingly
- Compliance for FDF
Requirements
Academic degree in Pharmacy, Chemistry or Biomedical field.
- Having at least 3-5 years experience in regulatory affairs and/or relevant health registration environments of medicinal products, preferably in the generic pharmaceutical industry
- Being familiar with the registration procedures and requirements in the global environment
- Having followed a wide range of professional training in Regulatory affairs field.
- Accuracy, creativity, trouble-shooting capability.
- Good communicator (open minded, transparent), good command of English
Benefits
Truly global work environment.
High performance culture.
Ability to make a difference.
Best in class compensation.
