Missoune Bakhouche

Senior Regulatory Affairs Executive – Genethics Regulatory Services – London (Genesis Group: Metwest, Chatfield, DDSA, Chelonia, Genethics UK).
Assemble and prepare data packages (original, amendments / variations, supplements) for generic, OTC and prescription medicine dossiers in current CTD format for submission to the MHRA
Review previous submissions & and new changes (change controls) to create submissions based on what is current and correct.

Perform maintenance tasks required to keep licenses up to date (National, DCP and MRP licences)

Review/approval and change implementation of product, formulations etc. based on global regulatory requirement and company policy. Maintain all product files (dossiers, correspondences from authorities and manufacturers).

Responsible for the co-ordination of some project activities (Change of Ownership, Activation licence & Transfer Pack).

Responsible for the development of site-specific project plans and the development of work processes / streams for the project execution.

Reviews and interprets regulatory submission documentation in the context of plant technical information, SOPs and documentation.