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.

Get similar jobs like these by email

By submitting your details you agree to our T&C's