Be responsible for managing regulatory submissions in terms of collection of data, review of site variations Be up-to-date with Guidance and MHRA & EU Regulations and provide assistance in evaluating proposed changes and deciding strategy, BE study queries Post approval change management To assist in thorough interpreting of RFIs, and outlining plan of action to respond to deficiencies To provide support/assistance to UK RA team by coordinating with suppliers/CMOs on Regulatory matters