Description
Compile high quality licence variation packages as well as working on upgrading existing EU and Rest of the World Marketing Authorisations to ensure regulatory compliance is maintained.Develop robust filing strategies working with the different site teams to ensure that licence packages are completed to the target dates stated in the 2014 regulatory work plan.
- Manage authoring and updating of regulatory Chemistry Manufacturing Controls (CMC) documents
- Ensures support to market affiliates for license renewals, line extensions, territory expansions and change of manufacturing sites
- Performs assessment of dossiers against manufacturing site practices and registered licenses in the markets
- Performs gap analysis of CMC information, determine remediation actions to correct non-compliance situations and define data requirements
- Manages completion of compliance assessments on product dossiers according to current International Conference on Harmonisation/Committee for Medicinal Products for Human Use (ICH/CHMP) guidelines and EU variation guidelines
- Adheres to client defined submission preparation timelines, ensures that regulatory documents are prepared accurately, completely and on-time
- Develops strong working relationships and acts as primary interface between Manufacturing sites and Regulatory Affairs on CMC change dossiers
Minimum Qualifications:
- Degree qualified in Chemistry, Pharmacy or Life Sciences or equivalent.
- Previous regulatory experience, and membership of a Regulatory Professional body.
- Current Good Laboratory Practice (cGLP), Current Good Manufacturing Practice (cGMP) , Regulatory procedures and requirements (European, US and ROW)
- Knowledge of Pharma Product development and validation processes.
- Excellent verbal and written communication skills
- Time and Organisation Management
- Able to work under pressure and to tight timelines
- Presentation skills
- Good negotiating/influencing skills