Regulatory Affairs Executive

Responsibility :

• 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