RA Project Manager

RA Project Manager

Job Title: RA Project Manager
Contract Type: Contract
Location: Berkshire
Salary: Negotiable
Start Date: ASAP
Reference: RPM01_1494861055
Contact Name: Alex Young
Contact Email:
Job Published: May 15, 2017 16:10

Job Description

Below is some key info -

Key Deliverable:

Create a re-baselined Module 3 for a sterile injectable product which is registered in multiple global markets (EU, Asia Pacific, AU/NZ).

Priority 1: Work with a partner company in the Asia Pacific region to customise for local content and publishing requirements to enable a complete update of their marketing authorisation.

Priority 2: Roll out the updated dossier to all other global markets.

Project considerations:

  • Include changes already planned for this speciality in the EU
  • Align with proposed updates being done in parallel for two other specialities within this Global MA (which includes Module 3, 4 and 5 updates)
  • Gap analysis against current Asia Pacific registration to identify variations required to update filing
  • Gap analysis against current EU registration to identify variations required to 're-baseline' in the EU
  • Develop strategy to enable roll-out of global updated dossier

Key skills:

CMC authoring, Global Regulatory Strategy, Coordination of SMEs, Ability to work with CROs, Ability to work with global Marketing Authorisation Holders.