Regulatory Country Approval Specialist

Are you an experienced Regulatory Country Approval Specialist? Do you have experience managing the preparation, review and coordination of Country Submissions? If so, this could be the perfect opportunity for you!We are recruiting for Regulatory Country Approval Specialist to join a globally leading CRO that provides comprehensive drug development and laboratory services to accelerate the delivery of new therapies to market.This role is offered on a contract basis initially for 6 months, Inside IR35 with a remote set up.Essential Job Functions/Responsibilities:Prepare, review and coordinate, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategyProvide, under guidance local regulatory strategy advice (MoH and/or EC) to internal clientsProvide project specific local SIA services and coordination of these projectsMay have contact with investigators for submission related activitiesKey-contact at country level for either Ethical or Regulatory submission-related activitiesCoordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activationMay work with the start-up CRA(s) to prepare ..... full job details .....