Description
EU Regulatory affairs professionalRemote working / Work from home
Our client requires an experienced EU regulatory affairs professional to backfill independent regulatory contractor's roles. The current onsite RA professional will manage projects and products within the Client portfolio, as outlined below.
The role requires that the EU Regulatory affairs professional will have the necessary product and procedural knowledge to represent Global Regulatory Affairs on project and submission teams. In addition the roles will include and not be limited to
*Product Owner of Centralised product accountable for
Annual reassessment,
PSUR,
New indication strategic advice
Manufacturing site transfer regulatory strategy
*Project management of EU variations (type I and II) including input and review of content
*Accountability for the regulatory procedural management
*Coordinate and input to preparation of scientific advice briefing documents
*Coordinate clinical trial and IND applications
*Propose and document regulatory strategies for major submissions
*Work proactively with other functions to develop documents for the above
*Coordinate national, mutual recognition, decentralised and centralised procedures working closely with functions plus affiliates
*Managing ad-hoc queries/activities
The role will be on site mostly for first 4-6 weeks to enable training in Client systems plus knowledge transfer but afterwards offsite/home-working. The start date will be as soon as possible to cover contractor leaving in 2 weeks. The ideal EU Regulatory affairs professional must ensure business continuity while addressing knowledge transfer and begin the transition to the long term model. After the initial training period the Regulatory affairs professional would be working from home and coming into the office depending on client requirements, approximately once a week but would be determined by the client.
Please get in contact ASAP, with your latest CV interviews will commence immediately.
People Source Consulting Ltd is acting as an Employment Business in relation to this vacancy.
People Source specialise in technology recruitment across niche markets including Information Technology, Digital TV, Digital Marketing, Project and Programme Management, SAP, Digital and Consumer Electronics, Air Traffic Management, Management Consultancy, Business Intelligence, Manufacturing, Telecoms, Public Sector, Healthcare, Finance and Oil & Gas.