Responsibilities:

Manage a team of registration officers (SROs & PROs)Ensure training, development and coaching of team members in order to meet individual and team objectivesCoordinate Confirmation of Submission Strategy (CoSS)Prepare and submit UK and MT national license applicationsProvide UK and MT national support for new product MR/DC or CP submissionsLiaise with UK the Commercial team to support UK launches, re-launches, switches and transfers (supply chain, demand/forecasting, marketing, pricing)Provide regulatory input for designated established products to ensure legal requirements are complied withPrepare and submit national variations, renewals, responses to questions, or other submissions as required to the National competent UK authorities according to agreed company procedures and objectivesAssist with the implementation of UK risk management plan activitiesRepresent UK regulatory affiliate at regulatory meeting with internal and external stakeholders, e.g., product launch meetings, UK commercial management meetings, BGMA, PAGB etc.Assist with company audits (internal/external) as appropriateAssist other UKRA team members produce documentation and submission dossiers of an acceptable standard

The minimum qualifications for this role are:

BSc or equivalent in Life Sciences or related area.Demonstrable experience in Regulatory Affairs. Must have 5-10yrs experience of full lifecycle of existing or new product registrations including strategy/planning, registrations, monitoring, post marketing approvals, through to launching in accordance with EU regulations.Experience managing a teamStrong MRP/DCP experienceMAA Applications and CMC changes

For further details, please contact Tim Barratt on (phone number removed) or email (url removed)