Interim Regulatory Affairs Project Manager

Recruiter
1st Executive
Location
Cambridge
Salary
GBP450 - GBP500 per day +
Posted
25 Sep 2019
Closes
25 Oct 2019
Ref
SS - 13143
Contact
Sam Solt
Specialist Area
Operations
Job Level
Manager, Specialist
Sector
Scientific
Hours
Full Time

Interim Regulatory Affairs Project Manager

Interim Regulatory Affairs Project Manager required for a 12 month contract in Cambridge.

You will provide project management support to the Regulatory Affairs team which is responsible for initial marketing applications, responses to regulatory questions, launch activities, variations and renewals.

Specific Responsibilities

  • Working closely with cross-functional submissions teams including Regulatory Affairs, CMC Regulatory Affairs, Publishing and In-country Affiliates to ensure that submissions are prepared to agreed timelines
  • Leading meetings with the cross-functional submission teams to plan, coordinate, prioritize, and track submissions for the region and/or specific countries.
  • Preparing and maintaining submission plans using MS Project.
  • Preparing materials to support the team in developing submission strategies and prioritising activities, such as Visio process maps.
  • Preparing and maintaining meeting outputs, action logs etc.
  • Developing risk strategies and maintaining risk logs.
  • Potential to work on special projects, process improvement projects and supporting EU RA teams as necessary

To be considered for the role you must have;

  • Project Management qualifications
  • 5+ years of Project Management experience
  • Strong understanding of pharmaceutical regulatory processes, manufacturing, change control and global distribution systems is an advantage
  • Risk management experience
  • Experience within a regulated industry is preferred

To discuss the Interim Regulatory Affairs Project Manager position please call Sam on 01483 213 304.